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58 Premature Infants Trials Near You
Power is an online platform that helps thousands of Premature Infants 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 PowerPulmonary Function Testing for Neonatal Respiratory Disorders
Birmingham, Alabama
This trial uses a new device to measure lung function in newborns by sending gentle airwaves into their lungs while they breathe normally. It targets term and preterm infants, especially those with lung diseases, because traditional methods are difficult and often require sedation. This method is easier and safer for measuring lung function in newborns.
No Placebo Group
Trial Details
Trial Status:Active Not Recruiting
Trial Phase:Unphased
Age:1 - 2
Key Eligibility Criteria
Disqualifiers:Major Malformation, Neuromuscular Condition, Terminal Illness, Others
1098 Participants Needed
DHA Supplementation for Premature Infants
Birmingham, Alabama
Growth-restricted very preterm infants (VPT) are born without adequate fat mass (FM) deposits and low docosahexaenoic acid (DHA) concentrations. They often experience further declines in DHA concentrations during the initial three weeks post-birth while advancing enteral feeds and receiving lipid supplementation predominantly through parenteral nutrition. These suboptimal enteral and parenteral nutrition practices significantly heighten the risk of faltering postnatal growth. One promising approach to mitigate these issues is enteral DHA supplementation. However, it remains unclear whether the early administration of DHA through enteral supplementation could lead to a more substantial increase in head growth without affecting FM accretion in growth-restricted VPT infants. To address this question, we propose a masked randomized clinical trial involving 152 VPT infants.
No Placebo Group
Trial Details
Trial Status:Recruiting
Trial Phase:Unphased
Age:24 - 72
Key Eligibility Criteria
Disqualifiers:Congenital Anomalies, Terminal Illness
152 Participants Needed
Breast Pumping for Preterm Birth
Birmingham, Alabama
The goal of this clinical trial is to learn about the effect of breast-pumping frequency on breast milk supply/ volume in mothers of preterm infants. The main question it aims to answer is:
- What effect does pumping frequency have on breast milk supply.
Researchers will compare breastmilk supply of mothers who pump every 2 hours to the supply of those who pump every 3 hours to see if there is a difference in the amount of breastmilk they produce.
Participants will be assigned to either pump every 2 hours or every 3 hours and record how many milliliters of breastmilk they produce daily for the first 28 days of their baby's life.
No Placebo Group
Trial Details
Trial Status:Recruiting
Trial Phase:Unphased
Age:< 28
Key Eligibility Criteria
Disqualifiers:Severe Illness, Under 18, Others
70 Participants Needed
PAL to Improve Oral Feeding for Infants With Chronic Lung Disease
Columbia, Missouri
The purpose of this study is to investigate the effects of the Pacifier Activated Lullaby (PAL) intervention on the transition to oral feeding for preterm infants with chronic lung disease and respiratory distress syndrome that require non-invasive respiratory support at 34 weeks PMA. This study will utilize a clinical trial design. Participants will be randomized into two groups. One group will receive the PAL intervention, the other group serving as a no contact control. Participants will be matched based on sex, gestational age at birth, and neurologic injury. Infants in the intervention group will receive two PAL sessions a week until successfully transitioned to \<2L of respiratory support and then receive one PAL session within 24 hours of their first oral feeding attempt.
No Placebo Group
Trial Details
Trial Status:Recruiting
Trial Phase:Unphased
Age:1 - 33
Key Eligibility Criteria
Disqualifiers:Other Music Therapy, Bowel Malformations, Others
60 Participants Needed
Early Feeding for Very Low Birth Weight Infants
Memphis, Tennessee
Feeding advancements in ELBW infants have evolved over decades. The fear of causing mortality and morbidity, notably NEC, have made providers cautious when advancing feeds. ELBW infants initially remained NPO for several days before initiating trophic feeds. However, data then showed that there was no increase in mortality and morbidity if trophic feeds were initiated earlier. Then data showed that a short duration of trophic feeds did not increase mortality and morbidity when compared to a prolonged duration. More recent data showed that enteral feeding should be initiated early, preferably within 24 hours of birth, because it may promote feeding tolerance, shorten the time to reach total enteral feeding, and reduce the incidence of extrauterine growth restriction and late onset sepsis without increasing the risk of developing NEC. The management of enteral nutrition in ELBW infants is still very variable. For example, there is no consensus on the optimal time point after birth at which enteral nutrition can be started. This study evaluates the benefits of starting feeds by 6 hours of life Purpose: The primary aim of this study is to evaluate if in infants ≤ 1000g birth weight, is there a benefit initiating feeds by 6 hours of life (compared to current feeding practice data of 3 days of life) on decreasing the time to attain full feeds in the first 30 days of life. The secondary aim is to evaluate if antenatal feeding discussions would streamline feeding management post-delivery.
No Placebo Group
Trial Details
Trial Status:Recruiting
Trial Phase:Unphased
Age:1 - 6
Key Eligibility Criteria
Disqualifiers:Congenital Malformations, Imminent Death, Others
Must Not Be Taking:Pressors
248 Participants Needed
Music Therapy for Premature Infants
New Haven, Connecticut
The investigators are conducting a two-site randomized control trial with the aim of defining the impact of music (M) without or with parent voice (MPV) on very preterm infants' acute and cumulative stress, intranetwork connectivity on term brain MRI, and language and other neurodevelopmental outcomes at two years corrected age. This is based on the hypothesis that infants in MPV arm are expected to experience the greatest benefit compared with infants receiving standard care.
No Placebo Group
Trial Details
Trial Status:Recruiting
Trial Phase:Unphased
Age:24 - 30
Key Eligibility Criteria
Disqualifiers:Genetic Anomalies, Severe Brain Injury, Others
243 Participants Needed
VTV for Bronchopulmonary Dysplasia
Springfield, Massachusetts
Despite significant improvement in preterm infant survival, the incidence of bronchopulmonary dysplasia (BPD) in infants born \< 28 weeks gestational age (GA) has been relatively stable at \~40%, with 10,000-15,000 new cases estimated annually. Delivery room (DR) management of preterm infants during the initial resuscitation has a significant impact on future development of BPD. Current DR practice as recommended by the Neonatal Resuscitation Program (NRP), focuses on providing positive pressure ventilation (PPV) for intubated infants based on pressure limited ventilation (PLV). But with rapidly changing pulmonary compliance during the early newborn period, PLV may lead to under or over inflation of the lungs and induce significant volutrauma, barotrauma and/or atelectotrauma, all of which are associated in the pathogenesis of BPD. No studies have specifically reported tidal volume (TV) provided in the DR in intubated infants with current PLV practices. Similarly, no study has evaluated the safety and efficacy of volume targeted ventilation (VTV) in the DR and its impact on BPD.
With the proposed study, in Phase I, the investigators aim to demonstrate that measuring TV in intubated infants receiving PPV via PLV is feasible. The investigators also seek to demonstrate that with PLV, TV is highly variable in the first few hours of life, even with the same peak inspiratory pressures (PiP) due to rapidly changing pulmonary compliance. A successful Phase I will demonstrate that measuring TV is feasible in the DR, and with information on real time actual TV achieved during PPV, it is possible to target the TV for a goal TV by adjusting the PiP provided.
Phase II will be a pilot randomized control trial to demonstrate feasibility of VTV compared to PLV. The investigators will also aim to understand the pulmonary mechanics and physiology during VTV. A successful Phase II will demonstrate VTV is feasible, is associated with stable TV, decreased peak inspiratory pressure and oxygen needs compared to PLV, and not associated with increased complications compared to PLV. It will thereby justify a larger randomized control trial with enough power to evaluate the efficacy of VTV in reducing BPD and other long term pulmonary morbidities for preterm infants.
No Placebo Group
Trial Details
Trial Status:Recruiting
Age:5 - 60
Key Eligibility Criteria
Disqualifiers:Not Listed
40 Participants Needed
Ultrasound Technique for Osteopenia in Premature Infants
Rochester, Minnesota
The goal of this project is to develop a new noninvasive ultrasound based technique, called vibro-acoustic analysis (VAA), for evaluation of infant bone health with particular application in assessment of bone health in premature infants who are at risk for bone disease.
No Placebo Group
Trial Details
Trial Status:Enrolling By Invitation
Trial Phase:Unphased
Age:3 - 8
Key Eligibility Criteria
Disqualifiers:Not Listed
50 Participants Needed
The goal of this clinical trial is to compare the microbiota of preterm babies born after premature breaking water with full-term babies microbiota.
The main questions it aims to answer are:
* Is babies' microbiota differs with premature water breaking than full-term babies microbiota?
* Is vaginal probiotics given to the mother influence the baby microbiota? Researchers will compare vaginal probiotics use to no treatment to see if the babies microbiota and mother microbiota is influenced.
Participants will
* Take vaginal probiotics between premature breaking water until delivery (group A)
* Keep a diary of their symptoms and compliance to treatment (group A)
* Take samples of vaginal secretions and of baby's stool (all groups)
No Placebo Group
Trial Details
Trial Status:Not Yet Recruiting
Trial Phase:Unphased
Sex:Female
Key Eligibility Criteria
Disqualifiers:Active Labor, Infection, Malformation, Others
Must Be Taking:Vaginal Probiotics
60 Participants Needed
Vaginal Probiotics for Premature Rupture of Membranes
Montreal, Quebec
The goal of this clinical trial is to evaluate the feasibility of the randomized controlled trial (RCT).
Secondary objectives include comparing the microbiota of preterm babies born after premature rupture of membranes across study groups.
To achieve this, participants will be asked to:
* Use the vaginal study product from the time of membrane rupture until delivery
* Keep a diary documenting their symptoms and treatment adherence
* Provide vaginal secretion samples and stool samples from their baby
Trial Details
Trial Status:Not Yet Recruiting
Trial Phase:Unphased
Sex:Female
Key Eligibility Criteria
Disqualifiers:Active Labor, Infection, Fetal Distress, Weakened Immune System, Others
Must Not Be Taking:Vaginal Probiotics, Oral Probiotics
80 Participants Needed
Early Diagnosis Practices for Cerebral Palsy
Montreal, Quebec
In this research, the investigators are using an implementation science approach to enhance the uptake of a clinical practice guideline for earlier diagnosis of cerebral palsy (i.e. what is being implemented) in neonatal follow-up clinics across Canada. This clinical practice guideline should be part of what neonatal follow-up specialists do in their routine clinical work with children born preterm. However, there is a wide variability in practice. The goal of this project is to harmonize practices in the neonatal follow-up community in agreement with international recommendations for earlier diagnosis of cerebral palsy. This research will measure if clinicians are truly following the clinical practice guideline. If not, implementation strategies that address barriers and leverage on facilitators will be deployed for successful uptake of the clinical practice guideline. This research will also assess whether implementation of the clinical practice guideline is associated with better patient outcomes.
No Placebo Group
Trial Details
Trial Status:Not Yet Recruiting
Trial Phase:Unphased
Age:2 - 30
Key Eligibility Criteria
Disqualifiers:Death, Major Malformation, Moved Outside Canada
2000 Participants Needed
Targeted Milk Fortification for Premature Infants
Boston, Massachusetts
This study is a randomized trial comparing 2 methods of human milk fortification for preterm infants in the neonatal intensive care unit (NICU). All participating infants will receive a human milk diet comprising maternal and/or donor milk plus multi-component and modular fortifiers. In one group (control), the milk will be fortified according to routine standard of care. In the other group (intervention), the fortification will be individually targeted based on the results of point-of-care human milk analysis. Outcomes include physical growth in the NICU and after discharge, brain structure by magnetic resonance imaging at term equivalent age, and neurodevelopment at 2 years.
No Placebo Group
Trial Details
Trial Status:Active Not Recruiting
Trial Phase:Unphased
Age:1 - 21
Key Eligibility Criteria
Disqualifiers:Congenital Anomaly, Growth Restriction, Others
130 Participants Needed
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 study is being done to see if outcomes for both a premature infant's parents and the infant born prematurely who have spent time in the neonatal intensive care unit (NICU) can be improved through parent cognitive behavioral therapy (CBT) sessions.
No Placebo Group
Trial Details
Trial Status:Recruiting
Trial Phase:Unphased
Key Eligibility Criteria
Disqualifiers:Congenital Anomalies, CPS Involvement, Others
100 Participants Needed
Oxygen Saturation Levels for Premature Infants
Dallas, Texas
This study is designed to answer one of the fundamental gaps in knowledge in the resuscitation of preterm infants at birth: What is the optimal target oxygen saturation (SpO2) range that increases survival without long-term morbidities? Oxygen (O2) is routinely used for the stabilization of preterm infants in the delivery room (DR), but its use is linked with mortality and several morbidities including bronchopulmonary dysplasia (BPD). To balance the need to give sufficient O2 to correct hypoxia and avoid excess O2, the neonatal resuscitation program (NRP) recommends initiating preterm resuscitation with low (≤ 30%) inspired O2 concentration (FiO2) and subsequent titration to achieve a specified target SpO2 range. These SpO2 targets are based on approximated 50th percentile SpO2 (Sat50) observed in healthy term infants. However, the optimal SpO2 targets remain undefined in the preterm infants. Recent data suggest that the current SpO2 targets (Sat50) may be too low. The investigators plan to conduct a multicenter RCT of Sat75 versus Sat50 powered for survival without BPD. The investigators will randomize 700 infants, 23 0/7- 30 6/7 weeks' GA, to 75th percentile SpO2 goals (Sat75, Intervention) or 50th percentile SpO2 goals (Sat50, control). Except for the SpO2 targets, all resuscitations will follow NRP guidelines including an initial FiO2 of 0.3. In Aim 1, the investigators will determine whether targeting Sat75 compared to Sat50 increases survival without lung disease (BPD). In addition, the investigators will compare the rates of other major morbidities such as IVH. In Aim 2, the investigators will determine whether targeting Sat75 compared to Sat50 increases survival without neurodevelopmental impairment at 2 years of age. In Aim 3, the investigators will determine whether targeting Sat75 compared to Sat50 decreases oxidative stress.
No Placebo Group
Trial Details
Trial Status:Recruiting
Trial Phase:Unphased
Age:0 - 10
Key Eligibility Criteria
Disqualifiers:Cyanotic Heart Disease, Diaphragmatic Hernia, Others
700 Participants Needed
High Protein Diet for Premature Infants
Houston, Texas
While new innovations in the care of extremely premature infants have led to decreased morbidity and mortality, poor postnatal growth remains as a major challenge. Early growth in the postnatal period influences neurodevelopmental and growth outcomes.
This proposed study will challenge current nutritional regimens for infants \< 1000 g birth weight (BW) by providing an exclusive human milk based diet with a higher amount of protein based on individual caloric and protein analysis of human milk utilizing targeted fortification. The investigators will evaluate the effects of a high versus standard protein enteral diet on growth and body composition in infants \< 1000 g BW.
There are no published studies evaluating the effect of an exclusive human milk protein diet on body composition in premature infants. Research has shown that infants who receive this diet achieve growth at targeted standards but body composition has not been evaluated. As an all human milk diet is well tolerated and associated with improved outcomes in the highest risk neonates, it is imperative to evaluate the benefits of a high protein exclusive human milk diet and the possible positive changes in body composition, specifically lean mass, in these infants.
Results from this proposed study will immediately influence current nutritional practices and will provide landmark information regarding targeted fortification with provision of adequate protein providing the most optimal body composition in the most fragile and vulnerable infants.
No Placebo Group
Trial Details
Trial Status:Active Not Recruiting
Trial Phase:Unphased
Age:14+
Key Eligibility Criteria
Disqualifiers:Major Congenital Anomalies, Congenital Heart Disease, Others
118 Participants Needed
Vitamin D for Premature Infants
Houston, Texas
Transitional formulas (22 kcal/oz) are recommended for infants less than 35 weeks gestation at birth. However, few data are available related to follow-up of infants receiving these formulas who were 28-34 weeks gestation at birth.
Primary hypothesis: Provision of supplemental vitamin D to a transitional formula will lead to higher serum 25-hydroxyvitamin D (25-OHD) levels and no infant with a serum 25-OHD less than 20 ng/mL when assessed at approximately 52 weeks post-menstrual age (PMA).
Trial Details
Trial Status:Active Not Recruiting
Trial Phase:Unphased
Key Eligibility Criteria
Disqualifiers:Bronchopulmonary Dysplasia, Major Congenital Anomalies, Others
Must Not Be Taking:Diuretics
39 Participants Needed
Vitamin D Supplementation for Premature Infants
Galveston, Texas
The objective of the study is to compare supplementation with vitamin D at 800 IU/day to usual care for the first 28 days after birth with respect to 25 (OH) vitamin D levels and indicators of likely or plausible effects of vitamin D supplementation on the function or structure of the lung, bones, immune system, and brain in extremely premature (EP) infants who are \<28 weeks gestational age (GA) or \<1000 grams of birth weight (BW). The study results will be analyzed as intention to treat Bayesian analyses (Frequentist analyses will also be performed).
Trial Details
Trial Status:Recruiting
Trial Phase:Unphased
Age:24 - 96
Key Eligibility Criteria
Disqualifiers:Congenital Anomaly, Nonbacterial Infection, Others
50 Participants Needed
Imaging Techniques for Hydrocephalus
Houston, Texas
The purpose of this study is to evaluate the safety and efficacy of ventricular microdosing of indocyanine green (ICG) in order to assess cerebrospinal fluid (CSF) ventricular dynamics and extracranial CSF outflow using fluorescent Cap-based Transcranial Optical Tomography (fCTOT) and Near-InfraRed Fluorescent (NIRF) imaging and to evaluate inflammation markers of the CSF and to correlate with CSF ventricular dynamics, extracranial outflow into the lymphatics, ventriculomegaly, and patient's clinical outcome in order to understand how inflammation may impact that status of extracranial outflow.
No Placebo Group
Trial Details
Trial Status:Recruiting
Trial Phase:Phase 1
Age:< 6
Key Eligibility Criteria
Disqualifiers:Allergy To Iodine Or ICG, Others
20 Participants Needed
Vitamin D Supplementation for Premature Birth
Houston, Texas
This trial is testing whether giving extremely premature infants a daily dose of vitamin D can improve their lung, bone, immune system, and brain health. The study focuses on babies born very early or with very low birth weight, who are at higher risk for health issues. Vitamin D supplementation has been studied extensively in preterm and low birth weight infants, showing improvements in growth and vitamin D status but mixed results on other health outcomes.
Trial Details
Trial Status:Recruiting
Trial Phase:Unphased
Age:24 - 96
Key Eligibility Criteria
Disqualifiers:Congenital Anomaly, Nonbacterial Infection, Others
180 Participants Needed
Why Other Patients Applied
"As a healthy volunteer, I like to participate in as many trials as I'm able to. It's a good way to help research and earn money."
IZ
Healthy Volunteer PatientAge: 38
"My orthopedist recommended a half replacement of my right knee. I have had both hips replaced. Currently have arthritis in knee, shoulder, and thumb. I want to avoid surgery, and I'm open-minded about trying a trial before using surgery as a last resort."
HZ
Arthritis PatientAge: 78
"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 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
Feeding Strategies Around Blood Transfusions for Necrotizing Enterocolitis
Halifax, Nova Scotia
The WHEAT International trial is a comparative effectiveness trial exploring whether withholding enteral feeds around the time of blood transfusion in very premature infants (\<30 weeks) will reduce the occurrence of Necrotizing Enterocolitis (NEC). Currently both continued feeding and withholding feeding are approved care practices. The current study will randomize infants from Neonatal Intensive Care Units (NICUs) across Canada and the United Kingdom (UK) into one of the two care approaches (withholding or continued feeds) to determine if any significant outcomes are found.
No Placebo Group
Trial Details
Trial Status:Recruiting
Trial Phase:Unphased
Age:< 30
Key Eligibility Criteria
Disqualifiers:Parental Opt-out, GIT Abnormality, NEC, Others
4333 Participants Needed
Oral Iron Supplements for Premature Infants
San Antonio, Texas
Study focuses on determining if daily versus every-other-day (EOD) oral iron at the same dose per kilogram per day will achieve similar incidence of iron replete status at 36 weeks post-menstrual age in premature neonates
No Placebo Group
Trial Details
Trial Status:Recruiting
Trial Phase:Unphased
Age:26 - 32
Key Eligibility Criteria
Disqualifiers:Congenital Anomalies, Chromosomal Abnormalities, Others
Must Be Taking:Oral Iron
100 Participants Needed
Maternal Voice Recording for Premature Infants
Albuquerque, New Mexico
A short-term randomized, blinded placebo-controlled trial, in premature infants in the neonatal intensive care unit (NICU) at 33-35 weeks post-conceptional age, of recorded maternal voice on quantitative EEG (spectral power density) as a marker of development.
Trial Details
Trial Status:Active Not Recruiting
Trial Phase:Unphased
Age:28 - 33
Key Eligibility Criteria
Disqualifiers:Cardiac Disease, Neurologic Disorder, Others
Must Not Be Taking:Antiepileptics, Sedatives
40 Participants Needed
Quality Improvement Care Bundles for Premature Birth
Medicine Hat, Alberta
The ABC-QI Trial aims to implement collaborative quality improvement (QI) strategies to standardize care for 32-36 week infants in Level 2 and 3 Neonatal intensive care units (NICUs) across the province of Alberta. The investigators want to know if using validated quality improvement methods and evidence-based care bundles will decrease the duration of hospital stay and get babies home as quickly as possible.
No Placebo Group
Trial Details
Trial Status:Recruiting
Trial Phase:Unphased
Age:32 - 36
Key Eligibility Criteria
Disqualifiers:Congenital Anomalies, Chromosomal Abnormalities, Others
9500 Participants Needed
Mindfulness-Based Stress Reduction for Mothers with Preterm Infants
Coeur d'Alene, Idaho
The overarching purpose of this study is to determine if a modified 8-week mindfulness-based intervention (with a focus on self-compassion; MBSC) or 8 weeks of 2000 IU vitamin D supplementation will reduce stress and increase self-compassion in mothers of preterm infants and beneficially modify the human milk produced, and subsequently improve infant health.
No Placebo Group
Trial Details
Trial Status:Recruiting
Trial Phase:Unphased
Age:18 - 50
Sex:Female
500 Participants Needed
Early Caffeine + LISA vs. CPAP for Neonatal Respiratory Distress Syndrome
Loma Linda, California
This trial is testing if giving a special liquid called surfactant to preterm babies using a gentle method can reduce the need for a breathing machine. The study focuses on babies born very early who are already getting some breathing support. The surfactant helps keep their lungs open, making it easier to breathe. Surfactant therapy has been a major contribution to the care of preterm newborns over the years.
No Placebo Group
Trial Details
Trial Status:Active Not Recruiting
Trial Phase:Unphased
Age:24 - 29
Key Eligibility Criteria
Disqualifiers:Congenital Anomalies, Unstable Birth, Others
180 Participants Needed
Darbe + IV Iron for Premature Infants
Seattle, Washington
This trial uses Darbepoetin and slow-release IV iron to help preterm infants. The treatment aims to reduce the need for blood transfusions, keep iron levels stable, and support better brain development without causing stomach problems.
No Placebo Group
Trial Details
Trial Status:Recruiting
Trial Phase:Phase 2
Age:< 3
Key Eligibility Criteria
Disqualifiers:Anomalies, High Hematocrit, High Iron, Infections, Others
120 Participants Needed
Calmer Therapy Bed for Premature Infants
Vancouver, British Columbia
Infants born preterm can spend months in the neonatal intensive care unit (NICU) where they experience stressful but essential procedures. Untreated stress is associated with altered brain development. Skin-to-skin care (SSC) is one of the most effective behavioral strategies for mitigating preterm infant stress and improving brain maturation. However, parents may not be always available to provide SSC; some infants cannot be held for long periods for medical reasons. To address this problem, investigators designed Calmer, a patented, prototype therapy bed, for reducing stress in preterm infants. Calmer fits into NICU incubators and provides simultaneously an artificial skin surface, heartbeat sounds and breathing motion, mimicking aspects of SSC; the latter 2 features are individualized for each infant based on their parents' recordings. The 1st randomized controlled trial (RCT) in 58 preterm babies showed that during a routine blood test: Calmer lowered infant behavioral and heart stress responses and stabilized brain blood flow no differently than facilitated tucking; infants could be cared for safely on Calmer up to 6 hours in 1 day; Calmer was well accepted by mothers and staff.
The goal now is to determine the efficacy of Calmer use over 3 weeks to support optimal physical growth and brain development in preterm infants. A 2-group (treatment, control) pilot RCT to test the implementation of an increased "dose" of Calmer exposure over 2-3 continuous weeks is proposed. 30 infants born between 26-30 weeks gestational age in the NICU will be randomized to receive either Calmer, for a minimum of 3 hours in total/day for 2-3 continuous weeks, or to 2-3 weeks of standard NICU care (minimum of 2 and maximum of 3 weeks).
Research questions:
Trial feasibility Q1. Is it feasible to enrol 30 infants, complete a 2-3-week treatment period (minimum of 2 and maximum of 3 weeks), and measure growth outcomes in preterm infants (26-30 weeks GA) in the NICU in a pilot RCT of daily Calmer treatment versus standard NICU care to inform a larger, definitive RCT?
Infant outcomes Q2a. Are there differences in physical growth markers (daily weight gain, head circumference, body length) between preterm infants who receive Calmer and those who receive standard NICU care measured before (baseline) and after 2-3 weeks of daily Calmer exposure? Q2b. Are there differences in brain activity markers, as measured by cerebral electrical (EEG) signalling, between preterm infants who receive Calmer and those who receive standard NICU care, measured during a resting/sleeping state and routine diaper change session at the end of the trial (post 2-3 weeks of daily Calmer exposure)?
No Placebo Group
Trial Details
Trial Status:Recruiting
Trial Phase:Unphased
Age:26 - 30
Key Eligibility Criteria
Disqualifiers:Congenital Anomalies, Infection, Cardiovascular Instability, Neurological Injury, Others
Must Not Be Taking:Paralytics
30 Participants Needed
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Frequently Asked Questions
How much do Premature Infants 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 Premature Infants 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 Premature Infants 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 Premature Infants 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 Premature Infants 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 Premature Infants clinical trials?
Most recently, we added T-piece Resuscitator vs Ventilator for Preterm Birth, Human Milk for Premature Infants and Vaginal Probiotics for Premature Rupture of Membranes to the Power online platform.
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