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75 Neonates Trials Near You
Power is an online platform that helps thousands of Neonates patients discover FDA-reviewed trials every day. Every trial we feature meets safety and ethical standards, giving patients an easy way to discover promising new treatments in the research stage.
Learn More About PowerMultimodal Intervention for Premature Birth
Columbus, Ohio
This prospective, randomized, controlled study evaluates the safety and efficacy of a preterm birth (PTB) prevention strategy versus standard of care pregnancy management to reduce the incidence of adverse pregnancy outcomes.
No Placebo Group
Trial Details
Trial Status:Active Not Recruiting
Trial Phase:Unphased
Sex:Female
Key Eligibility Criteria
Disqualifiers:Prior Preterm Delivery, Major Fetal Anomaly, Others
Must Not Be Taking:Progesterone, Heparin, Illicit Drugs, Others
6500 Participants Needed
Hyperpolarized Xenon MRI for Infant Lung Imaging
Cincinnati, Ohio
Abnormalities of the lungs are common in newborns and can include aspiration or infectious pneumonia, respiratory distress syndrome (RDS), bronchopulmonary dysplasia (BPD), pulmonary hypertension (PH), congenital diaphragmatic hernia (CDH), and other abnormalities of lung development. Diagnostic radiography is commonly used in this population to differentiate diagnosis and to assess changes after treatment. While X-ray and CT provide quality imaging, they also expose infants to ionizing radiation. MR imaging offers a safe, non-ionizing alternative. However, imaging lungs via 1H MR is intrinsically difficult due to multiple air-tissue interfaces within the lungs causing local gradients and severe magnetic field susceptibility, which leads to an exceedingly short effective transverse relaxation time (T2\*). Additionally, the lungs have low proton density, which along with the short T2\* results in low signal to noise ratio, and the physiological motion caused by respiration and cardiac pulsation further reduces lung signal. The development of more powerful hardware, along with faster MRI techniques, has enabled detailed noninvasive 1H MR imaging of pulmonary tissues. Additionally, the development of inhaled hyperpolarized gas MRI has led to breakthroughs in the ability to visualize and quantify regional ventilation and alveolar size.
No Placebo Group
Trial Details
Trial Status:Recruiting
Trial Phase:Phase 4
Age:< 6
Key Eligibility Criteria
Disqualifiers:ECMO, Respiratory Infection, Heart Disease, Others
Must Not Be Taking:Sedatives, Vasodilators, Inotropes, Others
12 Participants Needed
ATM-AVI for Bacterial Infections in Infants
Indianapolis, Indiana
The purpose of this study is to learn about the safety and effects of ATM-AVI for the possible treatment of infections caused by a type of bacteria called gram-negative bacteria.
The study medicine is a combination of an antibiotic, aztreonam (ATM), and another medicine, avibactam (AVI), which is used to help stop bacteria from being resistant to antibiotics. Antibiotics are medicines that fights bacteria and infections.
The study will include newborns and infants up to 9 months of age who are admitted in the hospital.
The study is conducted in 2 parts: Part A and Part B.
In Part A, all participants will receive a single intravenous (injected directly into a vein) infusion of ATM-AVI. This is to study the safety and effects of a single amount.
In Part B, all participants will receive multiple intravenous infusions of ATM-AVI as treatment for a possible or confirmed infection with gram-negative bacteria.
No Placebo Group
Trial Details
Trial Status:Recruiting
Trial Phase:Phase 2
Age:< 39
Key Eligibility Criteria
Disqualifiers:Severe Renal Impairment, Others
Must Be Taking:IV Antibiotics
48 Participants Needed
T-piece Resuscitator vs Ventilator for Preterm Birth
London, Ontario
Many extremely premature infants, born before 28 weeks' gestation age, require immediate help with breathing after birth. Positive pressure ventilation (PPV) using a device called a T-piece resuscitator is a common method. PPV is needed to establish proper lung function, improve gas exchange, and encourage the infant to breathe spontaneously. However, T-piece resuscitators have limitations, like a lack of visual feedback and variable settings, which may result in reduced effectiveness of PPV. Improving PPV effectiveness may reduce the need for more invasive procedures, such as intubation, which pose an increased risk of complications and death for these fragile infants. A novel approach, that may overcome the above limitations and deliver PPV with precise settings through a nasal mask, is to use a ventilator to deliver PPV (V-PPV) using a respiratory mode called nasal intermittent positive pressure ventilation (NIPPV). While NIPPV is commonly used in neonatal intensive care units to support breathing in premature infants, the impact of V-PPV use during immediate post-birth stabilization needs to be studied. Preliminary data from our recent single-center study confirmed the feasibility of using V-PPV for resuscitation of extremely premature babies and indicated its potential superiority with a 28% decrease in the need for intubation compared to historical use of T-piece. This promising innovation may enhance outcomes for these vulnerable infants by refining the way we provide respiratory support in their critical first moments. The research objective is to compare the clinical outcomes of extremely premature infants receiving manual T-piece versus V-PPV during immediate post-birth stabilization. The primary aim is to evaluate the impact of V-PPV on major health complications or death. This study seeks to provide insights into improving the care and outcomes of these infants during a critical stage of transition from fetus to newborn.
No Placebo Group
Trial Details
Trial Status:Not Yet Recruiting
Trial Phase:Unphased
Age:25 - 29
Key Eligibility Criteria
Disqualifiers:Outborn Birth, Major Anomaly, Others
780 Participants Needed
Acetaminophen + Ibuprofen for Patent Ductus Arteriosus
Hamilton, Ontario
This trial is testing a new combination of ibuprofen and IV acetaminophen to treat a heart problem in very premature babies. These babies often don't respond well to just one drug, so using two drugs together might work better. The goal is to see if this combination is safer and more effective than using ibuprofen alone. Ibuprofen is commonly used to close the ductus arteriosus in premature newborns, and IV acetaminophen has shown effectiveness in similar treatments.
Trial Details
Trial Status:Recruiting
Trial Phase:Phase 2
Age:< 27
Key Eligibility Criteria
Disqualifiers:Chromosomal Anomaly, Renal Dysfunction, Hepatic Dysfunction, Others
Must Be Taking:Ibuprofen
310 Participants Needed
Surfactant Therapy for Neonatal Respiratory Distress Syndrome
Evanston, Illinois
RESEARCH DESIGN Multicenter, randomized, controlled trial. RECRUITMENT Entry criteria Preterm infants 28-35 6/7 weeks' gestation and less than 48 hours of age who have a clinical diagnosis of respiratory distress syndrome. Infants who are on NCPAP and FiO2 ≥0.30 will randomized to curosurf or infasurf via MIST.
Exclusion criteria Infants will be excluded if there is a congenital anomaly or an alternative cause for respiratory distress.
Babies who require emergent intubation will not be enrolled in the interventions.
Parental Consent will be obtained prior to randomization.
No Placebo Group
Trial Details
Trial Status:Recruiting
Trial Phase:Phase 4
Age:< 48
Key Eligibility Criteria
Disqualifiers:Congenital Anomaly, Emergent Intubation, Others
262 Participants Needed
Amino Acid Requirements in TPN for Neonates
Toronto, Ontario
This trial tests how much of three important nutrients newborns need when fed through a tube. It focuses on babies who rely on this type of nutrition and uses a method to see how their bodies use these nutrients.
No Placebo Group
Trial Details
Trial Status:Recruiting
Trial Phase:Unphased
Age:1 - 28
Key Eligibility Criteria
Disqualifiers:Mechanical Ventilation, Infection, Enteral Feeding, Others
Must Not Be Taking:Protein Metabolism Drugs
60 Participants Needed
Neurally Adjusted Ventilatory Assist (NAVA) is a mode of ventilation where the electrical activity of the diaphragm (EDI) - a signal representing the baby's respiratory drive - is used to control the timing and amount of assist provided. NAVA was introduced to the market in 2007 and since has been used in more than 40 countries.
In the current clinical practice, the Edi signal from the patient is captured with miniature sensors (the size of a hair) embedded in the wall of a specially designed naso/orogastric feeding tube. This FDA and Health Canada approved, commercially available catheter (Getinge, Solna, Sweden), is 6 Fr in size (outer diameter), 49 cm in length and has 8 pairs of sensors that are placed 6 mm apart (so-called inter electrode distance (IED) is 6 mm).
While no obvious side effects have been noted by clinicians, for the smallest of neonates, the currently used commercial catheter (size 6F, 49 cm long) may have 'excessive' post-array catheter length. In these neonates, typically those with weight \< 1000 grams, following the correct placement of catheter as per the electrode array positioning at gastro-esophageal junction, the feeding holes in the catheter may end at the level of distal stomach instead of the desirable mid-stomach location. The changing demographics of the patients in the Neonatal Intensive Care Units (NICU) has created a clinical need to redesign the currently used Edi catheter specifically to suit the smallest of patients, such that following adequate placement the feeding holes sit at the level of mid-stomach. Drs. Christer Sinderby and Jennifer Beck in Toronto, Canada, are the original designers of the 6 mm/49 cm currently used Edi catheter. These investigators (at St-Michael's Hospital, Toronto) in collaboration with their team at Neurovent Research Inc. (NVR) have re-designed and invented a new prototype of the current FDA-approved catheter specifically suited for use in extreme premature neonates. They have done so by reducing the interelectrode distance from the originally set 6 mm to 4 mm, which reduces the overall insertion depth to capture the same signal from the diaphragm. All other parameters are exactly same as the original catheter (6F, 49 cm long).
In this small feasibility study the investigators wish to provide a clinical proof of concept for the use of this newly designed prototype in 10 extremely premature neonates who are already receiving NAVA ventilation in the NICU.
No Placebo Group
Trial Details
Trial Status:Active Not Recruiting
Key Eligibility Criteria
Disqualifiers:Not Listed
10 Participants Needed
The purpose of this study is to evaluate the safety and explore the PK/PD of L-CIT supplementation in preterm infants to prevent the development of inflammatory pathways initiated by low levels of plasma CIT, specifically in preterm infants with post surgical NEC and BPD±PH.
No Placebo Group
Trial Details
Trial Status:Recruiting
Trial Phase:Unphased
Age:1 - 6
Key Eligibility Criteria
Disqualifiers:Congenital Heart Disease, Sepsis, Others
60 Participants Needed
Prenatal Support Program for Premature Birth
Chapel Hill, North Carolina
The goal of this clinical trial is to learn if a personalized prenatal support program \[(Personalized Toolkit Building a Comprehensive Approach to Resource optimization and Empowerment in Pregnancy \& Beyond, (PTBCARE+)\] works to lower stress and lower the risk of early delivery in pregnant individuals at high-risk for delivering preterm. The main question\[s\] it aims to answer are:
* Does the PTBCARE+ patient support program lower patient-reported stress levels during pregnancy?
* Does the PTBCARE+ patient support program improve biologic measures of stress during pregnancy?
* Does the PTBCARE+ patient support program result in a higher chance of delivering a healthy baby at or close to full term?
Researchers will compare people who participate in the PTBCARE+ patient support program to those receive usual care to see if the PTBCARE+ patient support program lowers patient-reported stress, improves biologic measures of stress, and increases the chance of delivering a healthy baby at or close to full term.
Participants will be randomly assigned to receive the PTBCARE+ patient support program or usual prenatal care.
All participants will be asked to:
* complete 2 study visits during pregnancy - including completing electronic surveys, providing a blood and urine sample, measuring the heart rate variability by a clip or the ear or finger, and body composition evaluation using a simple scale-like device.
* complete one study visit postpartum that includes completing electronic surveys, and measuring heart rate variability. Blood and urine sample collection and body composition evaluation via InBody scale are optional at the postpartum visit.
People who are randomly assigned to receive the PTBCARE+ support program will receive several resources to help them during pregnancy. These things include items such as:
* a stress reduction toolkit;
* access to an online website that can also be downloaded as a smart phone app;
* the option to receive an electronic massage while in clinic, and more.
* additional support gifts provided at routine clinical appointments
People who are randomly assigned to receive usual prenatal care will not receive any additional support resources from the study during pregnancy.
No Placebo Group
Trial Details
Trial Status:Not Yet Recruiting
Trial Phase:Unphased
Sex:Female
Key Eligibility Criteria
Disqualifiers:Illicit Drug Use, Radical Trachelectomy, Major Congenital Anomaly, Others
1228 Participants Needed
Apneic Oxygenation for Neonatal Respiratory Failure
Philadelphia, Pennsylvania
Tracheal intubation in the NICU is frequently complicated by severe oxygen desaturation. Apneic oxygenation, a method of applying free flowing oxygen via nasal cannula to apneic patients undergoing intubation, prevents or delays oxygen desaturation during intubation in adults and older children. We propose to enroll patients at two sites (Hospital of the University of Pennsylvania and Children's Hospital of Philadelphia) in a randomized trial in infants undergoing intubation in the NICU to determine if apneic oxygenation, compared with no respiratory support or oxygen during laryngoscopy and intubation attempts (standard care), reduces the magnitude of oxygen desaturation during tracheal intubation encounters.
No Placebo Group
Trial Details
Trial Status:Recruiting
Trial Phase:Unphased
Age:0+
Key Eligibility Criteria
Disqualifiers:Airway Anomaly, Unstable Hemodynamics, Cyanotic Heart Disease, Others
110 Participants Needed
Light Therapy for Intraventricular Hemorrhage
Newark, New Jersey
The primary purpose of this study is to serve as a pilot study of the EFIL device treatment feasibility of IVH grades 3,4 to guide development of a larger trial. Primary outcomes will assess the following: safety of intervention, recruitment and consent process, acceptability of intervention by parents, retention rates, selection of most appropriate outcome measures, provide sample size estimates for a larger trial, increase the researchers\' experience with the study intervention. A complete list of objectives and aims are listed under "Objectives". This study hopes to treat 12-24 neonates using 650nm light of irradiance 10mW/cm2 for 5 minutes twice a day each day for 12 days. We will also call the parents at 6 months and 12 months to track developmental milestones.
No Placebo Group
Trial Details
Trial Status:Recruiting
Trial Phase:Unphased
Age:0 - 1
Key Eligibility Criteria
Disqualifiers:Older Than 1 Month, Others
24 Participants Needed
Suction Devices for Respiratory Failure in Infants
New York, New York
Preterm and term intubuted infants in the NICU will undergo two sequential suctioning procedures: a new, FDA-approved suction device called EXSALTA (ED) and the standard conventional wall (SCW). The physiological consequences, i.e. changes in heart rate (HR), oxygen saturation (SpO2), cerebral oxygenation (C-rSO2), and cerebral fractional oxygen extraction (C-FOE) between ED and SCW ETT tracheal suctioning system in both open and closed catheter system settings will be evaluated using a randomized cross over design in preterm and term infants receiving mechanical ventilation via an ETT. This study will evaluate the hypothesis that there will be significantly lower variations in HR, SpO2, C-rSO2, and C-FOE during ETT suctioning with ED compared to SCW suctioning systems under both open and close ETT suction settings.
No Placebo Group
Trial Details
Trial Status:Recruiting
Trial Phase:Unphased
Age:< 28
Key Eligibility Criteria
Disqualifiers:Cyanotic Heart Disease, Arrythmias
30 Participants Needed
Dexmedetomidine for Neonatal Sedation
Brooklyn, New York
Neonatal intubations are performed routinely in a NICU. Most intubations are still performed without the administration of medications (awake intubations). Some of the reasons are unavailability of a single good medication, the ease of administration, the physicians comfort level, side effects of medications including apnea, bradycardia, hypotension. Some units use a cocktail of different medications, each with their own side effects We are proposing to study the effects of a single medication, dexmedetomidine (precedex) for the purpose of sedation prior to intubation in neonates.
This study will compare the efficacy of a single dose of dexmedetomidine to controls.
No Placebo Group
Pivotal Trial (Near Approval)
Trial Details
Trial Status:Recruiting
Age:0+
Key Eligibility Criteria
Disqualifiers:Emergent Intubation, Low Birth Weight, Congenital Malformations, Hypotension, Heart Disease, Others
30 Participants Needed
Early Literacy Program for Preterm Infants
Birmingham, Alabama
The purpose of this study is to see if an early literacy and developmental program in addition to shared reading can increase developmental test scores at 24 months of age. All caregivers of infants in this study will receive shared reading training. Half of the caregivers will be trained in an additional coach-led caregiver-implemented early literacy and numeracy program. Information related to infant development will be collected from parent surveys, medical records, and questionnaires and assessments.
No Placebo Group
Trial Details
Trial Status:Not Yet Recruiting
Trial Phase:Unphased
Age:1 - 7
Key Eligibility Criteria
Disqualifiers:Major Malformation, Known Syndrome, Others
188 Participants Needed
Owlet Pulse Oximeter for Newborns
Birmingham, Alabama
The sponsor of this study, Owlet Baby Care, Inc., is comparing the accuracy of their pulse oximeter Sensor with the measurements of oxygen levels in newborns who are already being monitored with arterial blood samples. A minimum of 20, but up to 100 participants will be enrolled in a hospital environment and need to weigh 1500 grams or more. The purpose of the testing is to gather information on pulse oximeter readings taken by the Owlet OSS 3.0 Sensor and compare the readings to blood gas samples drawn by the medical staff. This will determine if the Owlet Sensor is accurate in newborns up to an age of 28 days after actual or expected delivery date.
The Owlet OSS 3.0 is the Sensor component within the Owlet Dream Sock, an over the counter, noninvasive pulse oximeter which is currently FDA cleared in infants 1-18 months and between 6 and 30lbs, meant to be used in the home environment. The Owlet Sock is a fabric wrap that secures the Sensor to a baby's foot. The Sensor estimates the baby's SpO2, pulse rate, and measures movement level, and transmits the wearer's readings to the paired Base Station via low energy BlueTooth energy.
No Placebo Group
Trial Details
Trial Status:Not Yet Recruiting
Trial Phase:Unphased
Age:0 - 28
Key Eligibility Criteria
Disqualifiers:Underdeveloped Skin, Limb Deformities, ECMO, Others
20 Participants Needed
Sildenafil for Neonatal Encephalopathy
Montreal, Quebec
Around the time of birth, some babies experience a condition called asphyxia, which means that their brain and other organs do not receive enough blood and/or oxygen to work properly. This life-threatening condition accounts for nearly 1 out of 4 deaths of all babies around the world, and often leads to severe brain damage, cerebral palsy, epilepsy, and trouble with learning and functioning in everyday life. At this time, no treatment is available to repair the brain damage caused by asphyxia. Excitingly, a drug called sildenafil (Viagra®) is already given safely to babies who suffer from increased blood pressure in their lungs' vessels. Recent studies using a laboratory model of asphyxia at birth suggest that sildenafil may also repair the brain damage caused by asphyxia. Similarly, recent small studies have shown that it is both feasible and safe to give sildenafil to human babies, who suffered from asphyxia at birth. These studies also highlight the first promising signs that sildenafil may improve how the brains of these babies work, which is consistent with the abovementioned laboratory studies.
On the basis of these previous researches, the investigators predict that sildenafil can repair the damage to a baby's brain. The investigators will test whether sildenafil can be safely given to a large group of human babies who suffer from asphyxia at birth, and will confirm whether sildenafil improves or not how their brains and hearts/lungs work.
This project will enable to determine whether sildenafil is a promising treatment for repairing brain damage in babies who suffer from asphyxia at birth. This project may also provide new solutions for these babies to improve their future life.
Trial Details
Trial Status:Recruiting
Trial Phase:Phase 2
Age:0 - 48
Key Eligibility Criteria
Disqualifiers:Congenital Heart Disease, Cerebral Malformations, Genetic Syndrome, Others
60 Participants Needed
Wireless Sensors for Neonatal Care
Montréal, Quebec
The goals of this observational study is to assess whether a new advanced wireless skin sensor vital sign monitoring system can effectively monitor the vital signs of healthy newborn infants (≥ 35 weeks gestational age). The main aims of this Study are to:
1. Assess feasibility
2. Evaluate safety
3. Determine accuracy of the wireless monitoring system, compared to the standard of care wired vital sign monitoring system, immediately after delivery and for the first 2h of age in the obstetrical center under unsupervised parents' care. The newborn infants participating in the Study will have both vital sign monitoring systems placed on their chest and limb. Their vital signs will be monitored for 2h consecutively.
No Placebo Group
Trial Details
Trial Status:Recruiting
Trial Phase:Unphased
Age:35 - 42
Key Eligibility Criteria
Disqualifiers:Preterm Birth, Unstable Condition, Skin Abnormalities
600 Participants Needed
Metformin for Infant Brain Injury
Boston, Massachusetts
Infants with hypoxic-ischemic encephalopathy (HIE) are at high risk for neurodevelopmental impairment, despite current standards of care. Adjunctive treatments to promote brain repair are needed. The antidiabetic drug metformin has recently been recognized as a neurorestorative agent, but, to date, has not been used in infants. Herein, the investigator describes a clinical trial with the aim of demonstrating the safety and feasibility of metformin use to improve neurodevelopmental outcomes in infants with HIE.
Stay on current meds
No Placebo Group
Trial Details
Trial Status:Not Yet Recruiting
Trial Phase:Phase 1
Age:3 - 6
Key Eligibility Criteria
Disqualifiers:Genetic Disorders, Liver Disease, Others
Must Not Be Taking:Antidiabetics, Steroids, Diuretics, Others
30 Participants Needed
Reading Therapy for Newborn Care
New Orleans, Louisiana
The primary purpose of this pilot study is to specifically examine the effect of parental reading on the ANS of mother and neonate in the hospital setting. The investigators will examine the effect of live maternal-infant reading on typically developing infants to better understand the physiological benefits of live reading on newborns.
No Placebo Group
Trial Details
Trial Status:Active Not Recruiting
Trial Phase:Unphased
Age:1 - 1
Key Eligibility Criteria
Disqualifiers:Hearing Disorder, Developmental Disability, Fetal Alcohol Syndrome, Others
1 Participants Needed
Why Other Patients Applied
"I've tried several different SSRIs over the past 23 years with no luck. Some of these new treatments seem interesting... haven't tried anything like them before. I really hope that one could work."
ZS
Depression PatientAge: 51
"I have dealt with voice and vocal fold issues related to paralysis for over 12 years. This problem has negatively impacted virtually every facet of my life. I am an otherwise healthy 48 year old married father of 3 living. My youngest daughter is 12 and has never heard my real voice. I am now having breathing issues related to the paralysis as well as trouble swallowing some liquids. In my research I have seen some recent trials focused on helping people like me."
AG
Paralysis PatientAge: 50
"I've been struggling with ADHD and anxiety since I was 9 years old. I'm currently 30. I really don't like how numb the medications make me feel. And especially now, that I've lost my grandma and my aunt 8 days apart, my anxiety has been even worse. So I'm trying to find something new."
FF
ADHD PatientAge: 31
"I was diagnosed with stage 4 pancreatic cancer three months ago, metastatic to my liver, and I have been receiving and responding well to chemotherapy. My blood work revealed that my tumor markers have gone from 2600 in the beginning to 173 as of now, even with the delay in treatment, they are not going up. CT Scans reveal they have been shrinking as well. However, chemo is seriously deteriorating my body. I have 4 more treatments to go in this 12 treatment cycle. I am just interested in learning about my other options, if any are available to me."
ID
Pancreatic Cancer PatientAge: 40
"I changed my diet in 2020 and I’ve lost 95 pounds from my highest weight (283). I am 5’3”, female, and now 188. I still have a 33 BMI. I've been doing research on alternative approaches to continue my progress, which brought me here to consider clinical trials."
WR
Obesity PatientAge: 58
Transpyloric Feeding for Very Low Birth Weight Infants
Saint Petersburg, Florida
Premature infants have high rates of bronchopulmonary dysplasia (BPD) due to prematurity of the participants' lungs and the need for prolonged respiratory support. These infants are at increased risk for gastroesophageal reflux and aspiration which may exacerbate lung injury. Transpyloric feeds, specifically duodenal feeds, may be used to bypass the stomach and directly feed the duodenum decreasing the amount of gastric reflux contributing to aspiration. Duodenal feeds are equivalent to gastric feeds with regards to nutritional outcomes, and have been shown to decrease events of apnea and bradycardia in premature infants. This study will evaluate the feasibility and safety of duodenal feeds in premature infants. The hypothesis is that duodenal feeds may be safely and successfully performed in premature very low birth weight infants.
No Placebo Group
Trial Details
Trial Status:Recruiting
Trial Phase:Unphased
Age:0 - 12
Key Eligibility Criteria
Disqualifiers:Low PH, Low APGAR, IUGR, Congenital Anomalies, Others
Must Not Be Taking:Hydrocortisone
30 Participants Needed
This trial tests if giving preterm infants fentanyl and atropine before a lung treatment can reduce the risk of low heart rate and low oxygen levels. The study focuses on infants born prematurely who have breathing problems. Fentanyl has been studied for its potential to reduce stress and improve outcomes in these infants.
Trial Details
Trial Status:Recruiting
Age:0 - 72
Key Eligibility Criteria
Disqualifiers:Severe Congenital Anomalies, Opioid Addiction, Others
58 Participants Needed
Delayed Cord Clamping with Oxygen for Premature Birth
San Diego, California
This trial tests whether giving preterm babies different oxygen levels while delaying umbilical cord clamping helps them breathe better. It focuses on very early preterm infants who often have trouble breathing. The goal is to see which method helps these babies get enough oxygen in their blood more quickly.
No Placebo Group
Trial Details
Trial Status:Active Not Recruiting
Trial Phase:Unphased
Age:22 - 28
Key Eligibility Criteria
Disqualifiers:Congenital Anomalies, Bleeding Accreta, TTTS, Others
140 Participants Needed
ECG-Guided Umbilical Vessel Catheterization for Acute Lymphoblastic Leukemia
Palo Alto, California
Umbilical venous catheters (UVC) are typically places with poor guidance and some radiological confirmation. Misplacement of the catheter could lead to its placement in other unintended anatomical areas such as the liver or the spleen, which could be detrimental in critically-ill infants. Our study aims at using a more non-invasive means of placing and continuously monitoring catheter placement using superficial electrocardiogram (ECG) tracings.
No Placebo Group
Trial Details
Trial Status:Recruiting
Trial Phase:Unphased
Age:1 - 45
Key Eligibility Criteria
Disqualifiers:No Consent, Clinically Unstable
150 Participants Needed
The objective of this study is to evaluate the efficacy of a rapid wean intervention compared with a slow-wean intervention in reducing the number of days of opioid treatment from the first dose of weaning to cessation of opioid among infants receiving an opioid (defined as morphine or methadone) as the primary treatment for neonatal opioid withdrawal syndrome (NOWS).
No Placebo Group
Pivotal Trial (Near Approval)
Trial Details
Trial Status:Active Not Recruiting
Trial Phase:Phase 3
Age:36+
Key Eligibility Criteria
Disqualifiers:Major Birth Defect, Major Surgery, Seizures, Others
Must Be Taking:Morphine, Methadone
189 Participants Needed
Estimate the risks and benefits of active treatment versus expectant management of a symptomatic patent ductus arteriosus (sPDA) in premature infants.
No Placebo Group
Pivotal Trial (Near Approval)
Trial Details
Trial Status:Active Not Recruiting
Trial Phase:Phase 3
Age:48 - 21
Key Eligibility Criteria
Disqualifiers:Cardiopulmonary Compromise, Congenital Heart Disease, Others
836 Participants Needed
Red Cell Transfusions for Premature Infants
Columbus, Ohio
The objective of the TOP trial is to determine whether higher hemoglobin thresholds for transfusing ELBW infants resulting in higher hemoglobin levels lead to improvement in the primary outcome of survival and rates of neurodevelopmental impairment (NDI) at 22-26 months of age, using standardized assessments by Bayley.
No Placebo Group
Pivotal Trial (Near Approval)
Trial Details
Trial Status:Active Not Recruiting
Trial Phase:Phase 3
Age:< 48
Key Eligibility Criteria
Disqualifiers:Congenital Heart Disease, Anemia, Others
Must Not Be Taking:Erythropoietin
1824 Participants Needed
Esophageal Stimulation for Neonatal Feeding Disorder
Columbus, Ohio
The goal of this study is to demonstrate safety, feasibility, and efficacy of a novel pharyngo-esophageal stimulation technique in restoring aerodigestive and swallowing functions in select infants at-risk for chronic gavage tube feeding or gastrostomy. The main aims are:
* To provide consistent activation of deglutition (the process of swallowing), swallowing-airway interactions, and peristalsis in order to decrease the risk of home tube feeding.
* To examine whether physical and manometric evidence-guided interventions and biofeedback will improve compliance, minimize parental stress, and increase satisfaction and perceived self-confidence with infant feeding.
Participants will have weekly pharyngo-esophageal stimulation guided by High Resolution Impedance Manometry (HRIM) for 4 weeks or until discharge, oral nutritive stimulation of at least 5 mL of prescribed milk with each feed, and weekly parental education and feedback regarding feeding progress.
No Placebo Group
Trial Details
Trial Status:Recruiting
Trial Phase:Unphased
Age:1 - 8
Key Eligibility Criteria
Disqualifiers:Chromosomal Anomalies, Craniofacial Malformations, Others
40 Participants Needed
This trial tests a mix of a steroid and a lung-helping substance on very premature babies to reduce severe lung problems or death. The treatment works by reducing lung inflammation and helping the lungs stay open. Steroids like dexamethasone have been used to treat and prevent chronic lung disease in infants, showing beneficial effects.
No Placebo Group
Prior Safety Data
Pivotal Trial (Near Approval)
Trial Details
Trial Status:Active Not Recruiting
Trial Phase:Phase 3
Age:< 48
Key Eligibility Criteria
Disqualifiers:Terminal Illness, Major Malformations, Others
Must Be Taking:Surfactant
1160 Participants Needed
The objective of the NeoPlaTT trial is to test whether, among extremely preterm infants born at 23 0/7 to 26 6/7 weeks' gestation, a lower platelet transfusion threshold, compared to a higher threshold, improves survival without major or severe bleeding up to 40 0/7 weeks' postmenstrual age (PMA).
No Placebo Group
Trial Details
Trial Status:Recruiting
Trial Phase:Unphased
Age:1 - 48
Key Eligibility Criteria
Disqualifiers:Comfort Care, Thrombocytopenia, No Vitamin K, Others
2433 Participants Needed
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We started Power when my dad was diagnosed with multiple myeloma, and I struggled to help him access the latest immunotherapy. Hopefully Power makes it simpler for you to explore promising new treatments, during what is probably a difficult time.
Bask GillCEO at Power
Frequently Asked Questions
How much do Neonates clinical trials pay?
Each trial will compensate patients a different amount, but $50-100 for each visit is a fairly common range for Phase 2–4 trials (Phase 1 trials often pay substantially more). Further, most trials will cover the costs of a travel to-and-from the clinic.
How do Neonates clinical trials work?
After a researcher reviews your profile, they may choose to invite you in to a screening appointment, where they'll determine if you meet 100% of the eligibility requirements. If you do, you'll be sorted into one of the treatment groups, and receive your study drug. For some trials, there is a chance you'll receive a placebo. Across Neonates trials 30% of clinical trials have a placebo. Typically, you'll be required to check-in with the clinic every month or so. The average trial length for Neonates is 12 months.
How do I participate in a study as a "healthy volunteer"?
Not all studies recruit healthy volunteers: usually, Phase 1 studies do. Participating as a healthy volunteer means you will go to a research facility several times over a few days or weeks to receive a dose of either the test treatment or a "placebo," which is a harmless substance that helps researchers compare results. You will have routine tests during these visits, and you'll be compensated for your time and travel, with the number of appointments and details varying by study.
What does the "phase" of a clinical trial mean?
The phase of a trial reveals what stage the drug is in to get approval for a specific condition. Phase 1 trials are the trials to collect safety data in humans. Phase 2 trials are those where the drug has some data showing safety in humans, but where further human data is needed on drug effectiveness. Phase 3 trials are in the final step before approval. The drug already has data showing both safety and effectiveness. As a general rule, Phase 3 trials are more promising than Phase 2, and Phase 2 trials are more promising than phase 1.
Do I need to be insured to participate in a Neonates medical study?
Clinical trials are almost always free to participants, and so do not require insurance. The only exception here are trials focused on cancer, because only a small part of the typical treatment plan is actually experimental. For these cancer trials, participants typically need insurance to cover all the non-experimental components.
What are the newest Neonates clinical trials?
Most recently, we added Early Literacy Program for Preterm Infants, NGAL Monitoring for Pediatric Acute Kidney Injury and Prenatal Support Program for Premature Birth to the Power online platform.
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