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85 Premature Birth Trials Near You
Power is an online platform that helps thousands of Premature Birth 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 PowerAspirin for Preterm Birth
Columbus, Ohio
This is a phase-III multi-center double-blind randomized clinical trial of 1,800 individuals with a history of prior preterm birth at less than 35 weeks gestation who are randomized to either 162 mg aspirin or 81 mg aspirin daily. The study drug will be initiated between 10 and 15 weeks gestation and continued through 36 weeks, 6 days gestation. The primary endpoint is recurrent preterm delivery or fetal death prior to 35 weeks, 0 days gestation.
No Placebo Group
Pivotal Trial (Near Approval)
Trial Details
Trial Status:Recruiting
Trial Phase:Phase 3
Age:14+
Sex:Female
Key Eligibility Criteria
Disqualifiers:Hypertension, Renal Disease, Cardiac Disease, Others
Must Not Be Taking:Anticoagulants, Glucocorticoids
1800 Participants Needed
BETTER Intervention for Pregnancy Outcomes
Columbus, Ohio
This is a pragmatic randomized control trial to evaluate the BETTER intervention compared to standard obstetrical care (control) to determine whether it helps to reduce maternal anemia and other adverse pregnancy outcomes. The BETTER intervention includes one motivational interviewing session and bi-weekly text messages to encourage patients to connect with resources that address their social needs, including housing, food, and transportation. Quantitative data will be used to study participant outcomes, including surveys, and electronic health record data.
No Placebo Group
Trial Details
Trial Status:Recruiting
Trial Phase:Unphased
Sex:Female
Key Eligibility Criteria
Disqualifiers:Sickle Cell Disease, Transfusion Plan, Others
550 Participants Needed
DHA + AA Supplements for Premature Birth Development
Columbus, Ohio
This is a continuation study to the Omega Tots trial (NCT01576783). The purpose of this study is to follow-up with participants of the original study to determine the long-term effect a daily fatty acid dietary supplement taken during toddlerhood might have on children born preterm now that they are 8.5-10.5 years old.
Trial Details
Trial Status:Enrolling By Invitation
Trial Phase:Unphased
Age:8 - 10
Key Eligibility Criteria
Disqualifiers:Child In Custody
377 Participants Needed
Multimodal 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
Parent Training for Premature Birth Outcomes
Columbus, Ohio
The purpose of the study is to test the effects of the ezParent (web-based parent training program) intervention and telephone coaching calls (coach) on parent and child outcomes after 3-, 6-, and 12-months. Parents (n=220) will be randomized using a 2 x 2 factorial design to: (1) ezParent+coach, (2) ezParent, (3) Active Control+coach, or (4) Active control. The investigators will address these aims:
1. Determine the independent and combined effects of ezParent and coaching calls on parent outcomes. H1: The ezParent and ezParent+coach groups will report greater improvements in parenting skills and self-efficacy and reductions in harsh and negative discipline; and exhibit observed improvements in parent-child emotional connection vs. active control H2: There will be a synergistic effect of ezParent and coaching calls on parent outcomes such that ezParent+coach will provide greater benefit than the sum of the main effects of ezParent or coaching calls.
2. Determine the independent and combined effects of ezParent and coaching calls on child outcomes. H3: The ezParent and ezParent+coach groups will report greater reductions in child behavior problems vs. active control. H4: There will be a synergistic effect of ezParent and coaching calls on child outcomes such that ezParent+coach will provide greater benefit than the sum of the main effects of ezParent or coaching calls.
3. Determine differences in ezParent engagement with and without coaching calls. Engagement will be assessed by frequency (the number of times parents use the program), activity (proportion of material completed), and duration (amount of time parents use the program). H5: Relative to the ezParent only group, the ezParent+coach group will exhibit higher engagement with the ezParent.
Trial Details
Trial Status:Active Not Recruiting
Trial Phase:Unphased
Age:20+
Key Eligibility Criteria
Disqualifiers:Profound Developmental Impairment
490 Participants Needed
Antibiotics for Premature Rupture of Membranes
Columbus, Ohio
To conduct an unblinded pragmatic randomized controlled trial (pRCT) "Improvement of PPROM Management with Prophylactic Antimicrobial Therapy (iPROMPT)" of a seven-day course of ceftriaxone, clarithromycin, and metronidazole versus the current standard of care of a seven-day course of ampicillin/amoxicillin and azithromycin or erythromycin to prolong pregnancy and decrease adverse perinatal outcomes among hospitalized pregnant individuals undergoing expectant management of PPROM \<34 weeks.
No Placebo Group
Trial Details
Trial Status:Recruiting
Trial Phase:Phase 4
Sex:Female
Key Eligibility Criteria
Disqualifiers:Infection, Allergy, Immunosuppression, Others
Must Not Be Taking:Prophylactic Antibiotics
56 Participants Needed
Periviable GOALS DST for Premature Birth
Columbus, Ohio
This trial tests a tool called Periviable GOALS DST, which helps parents of extremely premature babies make informed decisions by providing clear information and helping them clarify their values. It targets pregnant patients at risk of delivering very early.
No Placebo Group
Trial Details
Trial Status:Recruiting
Trial Phase:Unphased
Key Eligibility Criteria
Disqualifiers:Under 18, Incarcerated, Medically Unstable, Others
216 Participants Needed
Bevacizumab for Retinopathy of Prematurity
Columbus, Ohio
Type 1 retinopathy of prematurity in zone I represents the most severe type of ROP and has the worst prognosis. It is unknown whether low-dose bevacizumab will be successful in these severe cases. Also unknown is the timing and extent of peripheral retinal vascularization after low-dose bevacizumab compared with the standard dose. The current study will evaluate whether doses of 0.063 mg and 0.25mg are effective as treatment for type 1 ROP, with ROP and retinal vessels all in zone I.
No Placebo Group
Prior Safety Data
Trial Details
Trial Status:Recruiting
Trial Phase:Phase 2
Age:< 6
Key Eligibility Criteria
Disqualifiers:Previous ROP Treatment, Stage 4/5 ROP, Others
80 Participants Needed
OHB-607 for Bronchopulmonary Dysplasia
Columbus, Ohio
This trial is testing a new medicine to see if it can prevent a serious lung condition in very premature babies. The goal is to see if this new treatment works better at protecting their lungs and reducing the chances of developing chronic lung disease.
No Placebo Group
Trial Details
Trial Status:Recruiting
Trial Phase:Phase 2
Age:0 - 24
Key Eligibility Criteria
Disqualifiers:Congenital Malformation, Chromosomal Abnormality, Neurological Disease, Others
338 Participants Needed
Multisensory Intervention for Prematurity
Columbus, Ohio
This trial tests a new treatment for preterm babies that uses their mother's voice, touch, and scent to help their brain develop better. The treatment is aimed at babies born early who often have trouble with brain development. By giving these babies familiar and comforting sensory experiences, the treatment hopes to improve their long-term growth and abilities.
No Placebo Group
Trial Details
Trial Status:Active Not Recruiting
Age:32 - 36
Key Eligibility Criteria
Disqualifiers:Not Listed
248 Participants Needed
Cycled Phototherapy for Premature Infants
Columbus, Ohio
Cycled phototherapy (PT) is likely to increase survival over that with continuous PT among extremely premature infants (\< 750 g BW or \<27 weeks GA).
No Placebo Group
Trial Details
Trial Status:Active Not Recruiting
Trial Phase:Unphased
Age:22 - 27
Key Eligibility Criteria
Disqualifiers:Hemolytic Disease, Major Anomaly, Nonbacterial Infection, Others
1700 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
Hydrocortisone for Bronchopulmonary Dysplasia
Columbus, Ohio
The Hydrocortisone and Extubation study will test the safety and efficacy of a 10 day course of hydrocortisone for infants who are less than 30 weeks estimated gestational age and who are intubated at 14-28 days of life. Infants will be randomized to receive hydrocortisone or placebo. This study will determine if hydrocortisone improves infants'survival without moderate or severe BPD and will be associated with improvement in survival without moderate or severe neurodevelopmental impairment at 22 - 26 months corrected age.
Pivotal Trial (Near Approval)
Trial Details
Trial Status:Active Not Recruiting
Age:< 30
Key Eligibility Criteria
Disqualifiers:Not Listed
800 Participants Needed
Health Screening and Referral for Premature Birth
Cincinnati, Ohio
Up to a quarter of the families with preterm infants have unmet social needs, such as housing or job insecurity, which represent adverse social determinants of health (SDOH). Preterm infants are especially vulnerable to the social conditions they grow up in, with sustained impacts on function across multiple organ systems. The goal of this study is to translate an established model of SDOH screening and referral from the outpatient setting to the NICU, thereby maximizing the potential to offset the effects of adverse SDOH on vulnerable mother-preterm infant dyads.
No Placebo Group
Trial Details
Trial Status:Enrolling By Invitation
Trial Phase:Unphased
Sex:Female
Key Eligibility Criteria
Disqualifiers:Infant Death, Late Discharge, Others
882 Participants Needed
Parenting Program for Preterm Birth
Cincinnati, Ohio
Open pilot of a brief online parenting-skills intervention for young children ages 3-8 who were born very preterm (\< 32 weeks gestational age). Parent-child interactions, child behavior, parent functioning, and child white matter connectivity will be assessed pre- and post-intervention 10 weeks later.
No Placebo Group
Trial Details
Trial Status:Active Not Recruiting
Trial Phase:Unphased
Age:36 - 96
Key Eligibility Criteria
Disqualifiers:Unstable Caregiving, Psychiatric Hospitalization, Others
19 Participants Needed
Parenting Intervention for Preterm Birth
Cincinnati, Ohio
Many children born very preterm experience behavior problems, and existing resources for parenting these children are lacking. A pilot trial established the effectiveness of a preterm parenting intervention, I-Interact Preterm (I2P). This study proposes a three-arm randomized controlled trial (RCT) comparing the established seven-session I2P program, a microlearning delivery mode (I2P-Micro), and an internet resource comparison group (IRC). Outcomes will be assessed at pretreatment, post-treatment (12 weeks later), and at an extended follow-up six months post-randomization. These outcomes include parenting behaviors, child behavior problems, and parent distress. It is anticipated that both I2P and I2P-Micro will result in significant improvements relative to the IRC condition, with greater utilization expected in the I2P-Micro group.
No Placebo Group
Trial Details
Trial Status:Recruiting
Trial Phase:Unphased
Age:3 - 8
Key Eligibility Criteria
Disqualifiers:Under 18, Unstable Caregiving, Psychiatric Hospitalization, Others
90 Participants Needed
Antibiotics for Premature Rupture of Membranes
Cleveland, Ohio
A randomized, controlled, non-placebo trial to primarily assess the effect of oral, outpatient antibiotics (i.e., azithromycin and amoxicillin) on latency (i.e., proportion of patients that deliver within 28 days from membrane rupture) following previable, prelabor rupture of membranes between 18 0/7 and 22 6/7 weeks gestational age.
No Placebo Group
Trial Details
Trial Status:Recruiting
Trial Phase:Phase 4
Sex:Female
Key Eligibility Criteria
Disqualifiers:Fetal Anomaly, Vaginal Bleeding, Others
Must Be Taking:Antibiotics
88 Participants Needed
This trial is testing if community health workers can help pregnant women on Medicaid get and eat healthy food. Some participants will have food delivered to them, while others will receive support to buy healthy food. The goal is to see if this support improves their diet and health.
No Placebo Group
Trial Details
Trial Status:Recruiting
Trial Phase:Unphased
Sex:Female
124 Participants Needed
The aim of this proposal is to characterize the acute effect of early postnatal sound exposure on neuronal maturation of the respiratory control regions of the brain in preterm infants.
No Placebo Group
Trial Details
Trial Status:Recruiting
Trial Phase:Unphased
Age:1 - 5
Key Eligibility Criteria
Disqualifiers:Congenital Anomalies, Others
34 Participants Needed
Medically Tailored Groceries for Pregnancy
Cleveland, Ohio
Medically tailored groceries (MTG), involving grocery items to be prepared at home, selected by a nutritional professional based on a treatment plan, is a growing approach adopted by healthcare systems to address food insecurity in their patient populations, a leading contribution to health disparities such as poor birth outcomes within pregnant populations. However, transportation and other social needs can often hinder patient uptake of clinic-based approaches. Findings from this study will help to better understand how home delivery of MTGs, with and without supplemental education and support to improve food literacy, behavioral and health outcomes.
No Placebo Group
Trial Details
Trial Status:Not Yet Recruiting
Trial Phase:Unphased
Age:18 - 55
Sex:Female
Key Eligibility Criteria
Disqualifiers:Under 18 Years Old
360 Participants Needed
Why Other Patients Applied
"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
"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
"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
"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
"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
Therapeutic Speech Device for Premature Birth
Chagrin Falls, Ohio
The goal of this clinical study is to test a new, novel medical device designed to improve speech sound differentiation among hospitalized preterm infants. The device is designed to be used at an age equivalent to 32 weeks of gestation or older and to integrate readily into clinical practice for use by nurses and therapists staffing Level II to Level IV NICUs. Preterm born infants are at high risk for neurosensory impairments and developmental delays. In the NICU, infants are often deprived of infant-directed parental speech because of numerous challenges to parental visitation, resulting in reduced differentiation of speech sounds, altered brain structure and poor language outcomes.
The study will explore the effectiveness of a novel medical device designed for infant learning through contingent sucking on a pacifier equipped with a sensor for suck pressure/timing, connected to a speaker that delivers mother's voice.
The study will test the hypothesis that there will be a greater response difference between speech sounds on EEG, for infants receiving the suck-contingent mother's voice intervention than for infants hearing the same amount of non-contingent mother's voice from a speaker device.
Trial Details
Trial Status:Recruiting
Trial Phase:Unphased
Age:32 - 35
Key Eligibility Criteria
Disqualifiers:Ventilation, Congenital Malformations, Genetic Hearing Loss, Others
Must Not Be Taking:Sedatives, Seizure Medications
203 Participants Needed
Cervical Length Measurement Timing for Preterm Birth
Detroit, Michigan
The goal of this clinical trial is to determine the optimal timing for measuring cervical length (CL) during fetal anatomy surveys in pregnant individuals. This study focuses on improving the accuracy of cervical length assessments, which are critical for identifying individuals at risk for preterm birth. The main questions it aims to answer are:
* Does measuring cervical length at the beginning of the anatomy survey result in a higher proportion of scans meeting the nine CLEAR (Cervical Length Education and Review) criteria compared to measuring at the end of the survey?
* Does the use of sepia-filtered ultrasound images improve the proportion of scans meeting the nine CLEAR criteria compared to conventional grayscale images?
Researchers will compare two groups of participants randomized to have cervical length measured either at the beginning or at the end of the anatomy survey. Additionally, all participants will undergo cervical length measurements using both grayscale and sepia-filtered ultrasound imaging.
Participants will:
* Receive a patient information sheet through MyChart explaining the study and standard cervical length screening during anatomy surveys.
* Provide verbal consent for a transvaginal ultrasound and study participation.
* Be randomized to have their cervical length measured at either the start or end of the fetal survey.
* Undergo cervical length measurement using both grayscale and sepia-filtered ultrasound imaging modalities.
* This study involves no additional risks beyond those of routine clinical care and aims to enhance clinical practice by identifying optimal methods for cervical length assessment during pregnancy.
No Placebo Group
Trial Details
Trial Status:Recruiting
Trial Phase:Unphased
Sex:Female
Key Eligibility Criteria
Disqualifiers:Preterm Delivery, Cervical Insufficiency, Others
550 Participants Needed
Mobile Health Strategy for Premature Birth
Pittsburgh, Pennsylvania
Preterm births are defined as delivery prior to 37 weeks gestation and account for 35% of infant deaths in the first year of life. Early preterm birth are deliveries prior to 32 weeks gestation and account for more than 70% of neonatal deaths and 36.1% of overall infant mortality. Women who have delivered a preterm infant and who have a short pregnancy interval (time between giving birth and subsequent conception) have an increased risk of preterm birth in subsequent pregnancies. The investigators hope to understand if a mobile health strategy can be used to reduce spontaneous preterm births via improved patient engagement, care coordination, and adherence to recommended care vs a traditional paper-based health strategy.
No Placebo Group
Trial Details
Trial Status:Enrolling By Invitation
Trial Phase:Unphased
Age:16 - 50
Sex:Female
Key Eligibility Criteria
Disqualifiers:No Mobile Phone, No Prior Preterm Birth
256 Participants Needed
Indomethacin for Premature Birth
Pittsburgh, Pennsylvania
In Canada, about 900 babies each year are born very early (\<26 weeks of gestation) and have a high chance of dying or having a serious bleed in the brain. Families of these extremely preterm babies consider preventing severe brain bleeding as critical to their child's health and well-being. A medicine called indomethacin, when given intravenously in 3-doses, is known to reduce severe brain bleeding. But use of this drug is variable among clinicians working in the neonatal intensive care unit (NICU) due to (a) its side effects on the gut; (b) possible harm when used with other medications; (c) a notion that despite reducing brain bleeds, the child's long-term brain development is not improved. Emerging evidence suggests that a single low-dose indomethacin regimen may be equally effective in reducing severe brain bleeding as compared to a traditional 3-dose regimen.
The investigators propose a blinded randomized controlled trial, a study design where babies born \<26 weeks will be randomly assigned within 12 hours of birth to either a single dose of intravenous indomethacin or similar looking placebo in the form a saline solution. The study will test if a single dose indomethacin regimen is effective in improving survival of these babies without the devastating complication of severe brain bleeding. In this study the care providers and researchers will be unaware as to which baby receives indomethacin and which baby receives placebo to ensure no one's expectations or biases can influence the results.
The investigators will conduct the study in multiple NICUs across Canada, the United States and Australia and will enroll 500 babies born \<26 weeks or \<750 g birth weight over a period of 3 years. This study will help the investigators determine in the most unbiased way whether a single dose of indomethacin given immediately after birth in the smallest babies born \<26 weeks of gestation can safely and effectively reduce severe brain bleeding.
Pivotal Trial (Near Approval)
Trial Details
Trial Status:Not Yet Recruiting
Trial Phase:Phase 3
Age:0 - 12
Key Eligibility Criteria
Disqualifiers:Duct Dependent CHD, Renal Anomalies, Others
Must Not Be Taking:Inhaled Nitric Oxide, Hydrocortisone
500 Participants Needed
Antibiotics for Neurodevelopmental Outcomes in Preterm Infants
Pittsburgh, Pennsylvania
The NANO follow-up study is designed to determine whether a simple, cost-effective intervention- withholding antibiotics at birth- reduces clinically relevant outcomes such as behavioral and neurological impairment at 2 years of age. This study will be the largest study evaluating the effects of early antibiotics in children with comprehensive measures of neurodevelopment linked to genomic variants and microbiota interactions.
Pivotal Trial (Near Approval)
Trial Details
Trial Status:Not Yet Recruiting
Trial Phase:Phase 3
Age:23 - 30
Key Eligibility Criteria
Disqualifiers:Sepsis Risk, Respiratory Issues, Others
Must Not Be Taking:Antibiotics
802 Participants Needed
CPAP for Premature Birth
Indianapolis, Indiana
A Pragmatic Randomized Controlled Pilot Trial to Evaluate the Impact of Early Prophylactic Continuous Positive Airway Pressure with or without Supplemental Oxygen in Spontaneously Breathing Late Preterm Newborn Infants Born by Cesarean Delivery, Compared to No Early Prophylactic Continuous Positive Airway Pressure with or without Supplemental Oxygen, on the Need for Further Respiratory Support Leading to NICU Admissions.
No Placebo Group
Trial Details
Trial Status:Active Not Recruiting
Trial Phase:Unphased
Age:1 - 5
Key Eligibility Criteria
Disqualifiers:Congenital Anomalies, Pulmonary Hypoplasia, Others
120 Participants Needed
PEEP Levels for Premature Birth
Indianapolis, Indiana
Premature babies often need help immediately after birth to open their lungs to air, start breathing and keep their hearts beating. Opening their lungs can be difficult, and once open the under-developed lungs of premature babies will often collapse again between each breath. To prevent this nearly all premature babies receive some form of mechanical respiratory support to aid breathing. Common to all types of respiratory support is the delivery of a treatment called positive end-expiratory pressure, or PEEP. PEEP gives air, or a mixture of air and oxygen, to the lung between each breath to keep the lungs open and stop them collapsing.
Currently, clinicians do not have enough evidence on the right amount, or level, of PEEP to give at birth. As a result, doctors around the world give different amounts (or levels) of PEEP to premature babies at birth.
In this study, the Investigators will look at 2 different approaches to PEEP to help premature babies during their first breaths at birth. At the moment, the Investigators do not know if one is better than the other. One is to give the same PEEP level to the lungs. The others is to give a high PEEP level at birth when the lungs are hardest to open and then decrease the PEEP later once the lungs are opened and the baby is breathing.
Very premature babies have a risk of long-term lung disease (chronic lung disease). The more breathing support a premature baby needs, the more likely the risk of developing chronic lung disease. The Investigators want to find out whether one method of opening the baby's lungs at birth results in them needing less breathing support.
This research has been initiated by a group of doctors from Australia, the Netherlands and the USA, all who look after premature babies.
No Placebo Group
Trial Details
Trial Status:Recruiting
Trial Phase:Unphased
Age:23 - 28
Key Eligibility Criteria
Disqualifiers:Severe Pulmonary Hypoplasia, Major Congenital Anomaly, Others
906 Participants Needed
Antibiotics for Neonatal Infections
Pittsburgh, Pennsylvania
The goal of the NANO trial is to study the longstanding clinical practice of empirically administering intravenous antibiotics to extremely low birthweight (ELBW) infants in the first days of life. In this 802-subject multicenter placebo-controlled randomized clinical trial, the hypothesis to be tested is that the incidence of adverse outcomes is higher in babies receiving empiric antibiotics (EA) in the first week of life compared to babies receiving placebo. The study targets a population of ELBW infants in whom the clinical decision to use or not use EA is currently most challenging -- infants that are clinically stable that did not have a known exposure to intraamniotic infection and were not born preterm for maternal indications. The primary outcome is the composite outcome of late-onset sepsis (LOS), necrotizing enterocolitis (NEC), or death during the index hospitalization. Secondary safety outcomes will include total antibiotic days, days to full enteral feedings, and common morbidities in preterm infants that have previously been linked to EA, e.g. retinopathy of prematurity and bronchopulmonary dysplasia. Weight and length z-score, and head circumference, are standard measures to be collected weekly by clinical team per a standardized protocol.
Trial Details
Trial Status:Recruiting
Trial Phase:Phase 4
Age:23 - 4
Key Eligibility Criteria
Disqualifiers:Maternal Infection, Respiratory Insufficiency, Hemodynamic Instability, Major Congenital Anomalies, Others
Must Not Be Taking:Antibiotics
802 Participants Needed
Antenatal Corticosteroids for Premature Birth
London, Ontario
Antenatal corticosteroids (ACS) reduce the risks of neonatal death and morbidities in preterm infants, such as respiratory distress syndrome.
The standard of care for pregnant people at risk of preterm birth includes 2 doses of Celestone (for a total of 24 mg in Canada, or 22.8 mg in Australia) to accelerate fetal lung maturity.
The investigators plan to conduct a randomized controlled trial to determine whether half the usual dose (12 mg in Canada, or 11.4 mg in Australia) of Celestone is non-inferior to the standard double doses.
Trial Details
Trial Status:Recruiting
Trial Phase:Phase 4
Age:18 - 55
Sex:Female
Key Eligibility Criteria
Disqualifiers:Severe Asthma, Lupus, Covid, Others
Must Be Taking:Celestone
3254 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
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Frequently Asked Questions
How much do Premature Birth 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 Birth 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 Birth 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 Birth 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 Birth 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 Birth clinical trials?
Most recently, we added Prenatal Support Program for Premature Birth, Hormone Replacement Therapy for Premature Ovarian Failure and Medically Tailored Groceries for Pregnancy to the Power online platform.
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