Clinical trials: Infants, Extremely Premature
Infant, Newborn, Infant, Low Birth Weight
Delayed Cord Clamping in VLBW Infants
This study tested the feasibility of conducting a randomized controlled trial to vary the timing that doctors clamp the umbilical cord after birth in extremely low birthweight infants.
- Conditions
- Infant, Newborn, Infant, Low Birth Weight, Infant, Small for Gestational Age, Infant, Premature
- Trial name
- NCT01222364
- Testing
- Standard Cord Clamping, Delayed Cord Clamping
- Where
- 4 sites in United States
- Volunteers
- 54 people, healthy volunteers welcome
- Sponsor
- NICHD Neonatal Research Network
Bronchopulmonary Dysplasia
MRI in BPD Subjects
The investigators are wanting to learn more about early development of the lungs and to help them better understand prematurity and the development of a breathing disorder call BPD (Bronchopulmonary Dysplasia)
- Trial name
- NCT03657693
- Testing
- NICU MRI, Polysomnography
- Where
- United States
- Volunteers
- 160 people, healthy volunteers welcome
- Sponsor
- Children's Hospital Medical Center, Cincinnati
Bronchopulmonary Dysplasia, Apnea of Prematurity
Early Versus Late Caffeine for ELBW Newborns
Caffeine is routinely used in the management of apnea of prematurity. Extremely low birth weight (ELBW) infants are at higher risk of mortality and various neonatal morbidities such as bronchopulmonary dysplasia (BPD) for which…
- Trial name
- NCT02524249
- Testing
- Caffeine
- Where
- United States
- Volunteers
- 110 people
- Sponsor
- Wayne State University
Patent Ductus Arteriosus in Preterm Infants, Patent Ductus Arteriosus After Premature Birth
Prophylactic IV Paracetamol in Extremely Premature Infants
Purpose of the research Everyone is born with an opening between the chambers of the heart, called a ductus arteriosus. In most people, it closes on its own, but in infants born at less than 30 weeks or less than 1250 grams…
- Conditions
- Patent Ductus Arteriosus in Preterm Infants, Patent Ductus Arteriosus After Premature Birth, Patent Ductus Arteriosus (PDA), Patent Ductus Arteriosus in Premature Infants
- Trial name
- NCT07067177
- Testing
- Paracetamol (drug)
- Where
- 3 sites in Palestinian Territories
- Volunteers
- 40 people, healthy volunteers welcome
- Sponsor
- Al-Quds University
Preterm Birth
Effects of Mother's Voice and Heartbeat Sounds on Preterm Newborns
The purpose of this RCT is to learn more about how sounds that we experience in the womb can affect early development in premature infants.
- Trial name
- NCT01913288
- Testing
- Biological Maternal Sounds
- Where
- United States
- Volunteers
- 150 people
- Sponsor
- Brigham and Women's Hospital
Low Birth Weight
Probiotics-Supplemented Feeding in Extremely Low Birth Weight Infants
The overall purpose of this research is to test whether adding a supplement to the feeding of extremely low birth weight infant (infants weighing less than 2 pound 2 oz at birth) will help him/her achieve full feeding faster and…
- Trial name
- PAS (NCT01164124)
- Testing
- Probiotic supplementation (Lactobacillus rhamnosus GG and Bifidobacterium infantis)
- Where
- 3 sites in United States
- Volunteers
- 101 people
- Sponsor
- Vermont Oxford Network
ROP, Jaundice, Neonatal
Hyperbilirubinemia and Retinopathy of Prematurity in Preterm Infants: a Retrospective Study.
The goal of this retrospective observational study is to [learn about the correlation between hyperbilirubinemia and retinopathy of prematurity in preterm infants.
- Conditions
- ROP, Jaundice, Neonatal, Premature, Very Low Birth Weight Infant
- Trial name
- biliROP (NCT05806684)
- Testing
- ROP
- Where
- Italy
- Volunteers
- 1,586 people
- Sponsor
- Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
Late-Onset Neonatal Sepsis, Extreme Prematurity
Dopamine vs. Norepinephrine for Hypotension in Very Preterm Infants With Late-onset Sepsis
Fluid-unresponsive hypotension needing cardiotropic drug treatment is a serious complication in very preterm neonates with suspected late-onset sepsis (LOS; defined as culture positive or negative bloodstream infection or…
- Conditions
- Late-Onset Neonatal Sepsis, Extreme Prematurity, Neonatal Hypotension
- Trial name
- NCT05347238
- Testing
- Dopamine, Norepinephrine
- Where
- 22 sites in United States, Canada and 3 more
- Volunteers
- 550 people
- Sponsor
- Mount Sinai Hospital, Canada
Patency of the Ductus Arteriosus Acetaminophen Extreme Prematurity
Long Term Follow-up of the TREOCAPA Study (TREOCAPA-LT)
The ductus arteriosus (DA) is a large channel connecting the main pulmonary trunk with the descending aorta. In extremely preterm infants, the DA frequently fails to close and this results in a condition called patent ductus…
- Trial name
- TREOCAPA-LT (NCT06064825)
- Testing
- 2 year follow-up of neurodevelopment using a parental questionnaire
- Where
- 8 sites in France
- Volunteers
- 500 people
- Sponsor
- Institut National de la Santé Et de la Recherche Médicale, France
Ductus Arteriosus, Patent
High-dose Ibuprofen for Patent Ductus Arteriosus (PDA) in Preterm Infant
The investigators hypothesized that the early treatment of PDA with ibuprofen doses higher than those actually recommended might increase the closure rate in preterm infants with gestational age <29 weeks without increasing the…
- Trial name
- NCT01243996
- Testing
- Ibuprofen
- Where
- Italy
- Volunteers
- 70 people
- Sponsor
- University of Florence
Extreme Prematurity, Respiratory Distress Syndrome
LISA in the Delivery Room for Extremely Preterm Infants
The purpose of this study is to evaluate the effect of LISA used in the delivery room (DR) in decreasing the intubation rates in preterm infants at 22-25 weeks gestational age (GA), during first 72 hours compared to the standard…
- Trial name
- DRLISA (NCT04715373)
- Testing
- LISA
- Where
- United States
- Volunteers
- 60 people
- Sponsor
- University of Texas Southwestern Medical Center
Pulmonary Hypertension, Infant, Premature
Novel Echocardiographic Methods for Early Identification of Neonates at Risk for Chronic Pulmonary Hypertension
Chronic pulmonary hypertension (cPHT) is a serious cardiopulmonary disorder that causes low oxygen levels in the blood, difficulty in breathing and ultimately heart failure.
- Trial name
- NCT04402645
- Where
- 6 sites in United States, Canada and 2 more
- Volunteers
- 350 people
- Sponsor
- Mount Sinai Hospital, Canada
Premature Infant, Extremely Low Birth Weight
Time to Accurate Heart Rate on Neonatal Outcomes
The goal of this trial is to compare the time to first heart rate displayed for iRes Warmer with ResusView and using iRes Warmer without ResusView when used in the resuscitation (e.g.
- Conditions
- Premature Infant, Extremely Low Birth Weight, Extreme Prematurity
- Trial name
- GE-EKG (NCT04587934)
- Testing
- iRes Warmer with ResusView, iRes Warmer without ResusView
- Where
- United States
- Volunteers
- 42 people
- Sponsor
- Sharp HealthCare
Premature Birth, Ventilator Lung; Newborn
sNIPPV Versus NIV-NAVA in Extremely Premature Infants
The aim of this study is to demonstrate a significant decrease in asynchrony with NIV-NAVA using the Servo n ventilator (Getinge, Sweden), as compared to abdominal triggered (Graseby capsule) synchronized nasal intermittent…
- Trial name
- EASYNNEO (NCT04068558)
- Testing
- VNI-NAVA/sNIPPV, sNIPPV/VNI-NAVA
- Where
- France
- Volunteers
- 14 people
- Sponsor
- Centre Hospitalier Intercommunal Creteil
Retinopathy of Prematurity
Effects of Early Vitamin A Supplementation on the Risk for Retinopathy of Prematurity in Extremely Preterm Infants
Retinopathy of prematurity (ROP) is a common retinal neovascular disorder and major cause of vision impairment or blindness, despite current treatment of late stage ROP.
- Trial name
- NCT03154723
- Testing
- Vitamin A
- Where
- China
- Volunteers
- 262 people, healthy volunteers welcome
- Sponsor
- Huiqing Sun
Infant, Premature, Feeding Behavior
Effects of the Oral Stimulation Program in Extreme Preterm Infants
The purpose of this study is to determine whether oral stimulation program are effective to improve oral feeding efficiency. The sample size estimated in 74 preterm, randomized classification of the subjects into to experimental…
- Trial name
- NCT03025815
- Testing
- Intervention group, Control group
- Where
- Brazil
- Volunteers
- 74 people
- Sponsor
- Hospital de Clinicas de Porto Alegre
Infant, Newborn, Infant, Low Birth Weight
Persistent Pulmonary Hypertension of the Newborn (PPHN) Observational Study
This study was an observational study to estimate the prevalence of Persistent pulmonary hypertension of the newborn (PPHN) among term or near-term infants with severe respiratory disease.
- Conditions
- Infant, Newborn, Infant, Low Birth Weight, Infant, Small for Gestational Age, Infant, Premature
- Trial name
- PPHN (NCT01203423)
- Where
- 13 sites in United States
- Volunteers
- 385 people
- Sponsor
- NICHD Neonatal Research Network
Understanding of Consent in Clinical Research, Implementation of Video-Consent in Clinical Research
Impact of Video-Enhanced Consent on Informed Decision-Making for Parents of Extremely Preterm Infants Eligible for the ViDES Study
This pilot randomized controlled trial evaluates the impact of video-enhanced consent compared to the usual approach. The investigators aim to assess if video-enhanced consent empowers decision-making and improves understanding…
- Trial name
- NCT06446492
- Testing
- ViDEO explaining study, Usual Care
- Where
- United States
- Volunteers
- 83 people, healthy volunteers welcome
- Sponsor
- The University of Texas Health Science Center, Houston
Extreme Prematurity, Enteral Nutrition
High-energy Human Milk Diets in the First Two Weeks After Birth to Reduce BPD in Extremely Preterm Infants
This Phase II, parallel-group, masked, randomized clinical trial aims to evaluate whether a DHA/ARA-enriched, fortified human milk diet administered during the first 14 days of life reduces respiratory morbidity and improves lung…
- Conditions
- Extreme Prematurity, Enteral Nutrition, Bronchopulmonary Dysplasia
- Trial name
- MEND-BPD (NCT07307612)
- Testing
- High-energy group, Standard-energy group
- Where
- United States
- Volunteers
- 150 people
- Sponsor
- University of Alabama at Birmingham
Bronchopulmonary Dysplasia, Encephalomalacia
Randomized Trial of Hydrocortisone in Very Preterm High-Risk Infants
The purpose of this study is to determine whether treatment of very preterm infants at high-risk for lung and brain injury with low dose hydrocortisone results in improved pulmonary and neurologic outcomes.
- Conditions
- Bronchopulmonary Dysplasia, Encephalomalacia, Premature Birth
- Trial name
- NCT00167544
- Testing
- Hydrocortisone
- Where
- United States
- Volunteers
- 64 people
- Sponsor
- Nationwide Children's Hospital