Clinical trials: Very Preterm Birth
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
Infant, Newborn, Infant, Low Birth Weight
Early-Onset Sepsis Surveillance Study
In this observational study, the NICHD Neonatal Research Network (NRN) is conducting surveillance of all infants born at NRN centers to identify all newborns who are diagnosed with early-onset sepsis (EOS) and/or meningitis.
- Conditions
- Infant, Newborn, Infant, Low Birth Weight, Infant, Small for Gestational Age, Infant, Premature
- Trial name
- EOS (NCT00874367)
- Where
- 19 sites in United States
- Volunteers
- 615 people, healthy volunteers welcome
- Sponsor
- NICHD Neonatal Research Network
Very Low Birth Weight Infants
Cognitive and Behavioral Outcomes of School-aged Children Who Were Born Preterm
This study evaluates the cognitive and behavioral outcomes including image findings of school-aged children who were born preterm compared with who were born term gestational age.
- Trial name
- NCT02741934
- Where
- South Korea
- Volunteers
- 111 people, healthy volunteers welcome
- Sponsor
- Seoul National University Hospital
Infant Development
Differences Between the Bayley-II and the Bayley-III in Very Preterm Infants at 2 Years
The objective of this randomized study is to test the hypothesis that scores on the Bayley Scales of Infant Development-III (Bayley-III) are higher than scores on the Bayley Scales of Infant Development-II (BSID-II) in the same…
- Trial name
- NCT01373177
- Testing
- Bayley Scales of Infant Development-II, Bayley Scales of Infant Development-III
- Where
- United States
- Volunteers
- 119 people, healthy volunteers welcome
- Sponsor
- Children's Hospital of Philadelphia
Gut Microbiota, Metabolites
Targeting Gut Microbiota and Metabolites for Very Preterm Infants Through Oropharyngeal Administration of Colostrum
Background: Oropharyngeal administration of colostrum (OAC) has an immune stimulating effect on oropharyngeal-associated lymphoid tissue, and can also promote the maturation of the gastrointestinal tract.
- Trial name
- NCT05481866
- Testing
- Oropharyngeal administration of colostrum, Oropharyngeal administration of sterile water
- Where
- China
- Volunteers
- 320 people, healthy volunteers welcome
- Sponsor
- Shenzhen People's Hospital
Bronchopulmonary Dysplasia, Very Low Birth Weight Infant
Work of Breathing in Premature Infants at Discharge
The purpose of this study is to compare how premature infants who required oxygen for at least 28 days during their time in the NICU (Neonatal Intensive Care Unit) breathe at discharge compared to premature infants who did not…
- Conditions
- Bronchopulmonary Dysplasia, Very Low Birth Weight Infant, Prematurity
- Trial name
- NCT03682575
- Testing
- Enrollment
- Where
- United States
- Volunteers
- 78 people, healthy volunteers welcome
- Sponsor
- Christiana Care Health Services
Prematurity, VLBW - Very Low Birth Weight Infant
Self Regulated Physical Activity and Bone Growth Enhancement in Premature Infants
Premature very low birth weight (VLBW) infants were placed in two groups matched for birth age. The control group received traditional joint compression exercises designed to decrease bone density loss.
- Trial name
- NCT03884322
- Testing
- Prepod, Joint compression exercises
- Where
- United States
- Volunteers
- 54 people, healthy volunteers welcome
- Sponsor
- Asante Health System
Sepsis, Neonatal
Comparison Between Split Septum and Mechanical Valve Needleless Connector in Preterm Babies
The goal of this clinical trial study is to compare the effectiveness between split septum and mechanical valve needleless connector in very preterm babies (or under 1500 grams) The main questions it aims to answer are: What is…
- Trial name
- NCT06414174
- Testing
- Split septum needleless connector, Mechanical valve needleless connector
- Where
- Indonesia
- Volunteers
- 60 people, healthy volunteers welcome
- Sponsor
- Universitas Indonesia
Preterm Birth
Human Milk in Preterm Infants
Current NICU protocol introduces human milk fortifier at 8 days of feeding. This study will introduce human milk fortifier at day 1. The primary outcome is the effect on growth velocity at 28 days and 36 weeks post menstrual age.
- Trial name
- NCT05228535
- Testing
- Human milk fortifier
- Where
- United States
- Volunteers
- 50 people, healthy volunteers welcome
- Sponsor
- Augusta University
Very Premature Baby
Attention Control Training (ACT) and Very Preterm Infants
Infants' attention control, defined as the ability to select what to pay attention to, is a fundamental building block for developing learning abilities and behaviour self-regulation.
- Trial name
- ACT (NCT03896490)
- Testing
- Attention Control Training, Control
- Where
- United Kingdom
- Volunteers
- 12 people, healthy volunteers welcome
- Sponsor
- Queen's University, Belfast
Neonatal Prematurity, Massage Therapy
Massage Therapy in Premature Neonates
The goal of this clinical trial is to learn about the effects of Neonatal Touch and Massage Therapy on premature babies. The main questions it aims to answer are: Do babies who receive Neonatal Touch and Massage Therapy get…
- Trial name
- NCT06163586
- Testing
- Neonatal Touch and Massage Therapy
- Where
- United States
- Volunteers
- 32 people, healthy volunteers welcome
- Sponsor
- University of Maryland, Baltimore
Bronchopulmonary Dysplasia, Child Development
Enteral High-dose DHA Supplementation on Bronchopulmonary Dysplasia in Very Preterm Infants: a Collaborative Study
This one-stage individual participant data (IPD) meta-analysis study will aim to determine whether high-dose docosahexaenoic acid (DHA) enteral supplementation during the neonatal period is associated with the risk for severe…
- Conditions
- Bronchopulmonary Dysplasia, Child Development, Neonatal and Perinatal Conditions
- Trial name
- NCT05915806
- Testing
- High-dose DHA, Control
- Where
- Canada
- Volunteers
- 1,801 people, healthy volunteers welcome
- Sponsor
- CHU de Quebec-Universite Laval
Anemia of Prematurity, Very Low Birth Weight Infant
Iron Supplementation and Intestinal Health
This is a randomized double-blinded study of enteral iron supplementation in Very Low Birth Weight infants. The subjects will be randomized into low dose (2 mg/kg/day) and high dose (6 mg/kg/day) of daily iron supplementation.
- Trial name
- NCT04497012
- Testing
- 2mg/kg/day Iron Sulfate, 6 mg/kg/day Iron Sulfate
- Where
- United States
- Volunteers
- 183 people, healthy volunteers welcome
- Sponsor
- University of South Florida
Olive Oil Adverse Reaction, Nursing Caries
Effect of Enteral Olive Oil Supplement On Weight Gain and Development of Some Complications in Preterm
Objective: The objective of the present research is to compare the nutritional status, weight gain, length of hospital stay, and development of some complications in very low birth-weight (VLBW) infants who received and did not…
- Conditions
- Olive Oil Adverse Reaction, Nursing Caries, Enteral and Supplement Feeds Adverse Reaction, Preterm
- Trial name
- NCT05815849
- Testing
- Olive oil
- Where
- Turkey (Türkiye)
- Volunteers
- 96 people, healthy volunteers welcome
- Sponsor
- Kocaeli University
Weight Gain Preterm
Strategy to Minimize In-hospital Malnutrition in Premature Babies
Adequate nutrition is important for preventing malnutrition in the postnatal period and thus optimize growth and development of children born prematurely.
- Trial name
- SPN (NCT01217164)
- Testing
- no intervention
- Where
- Brazil
- Volunteers
- 64 people, healthy volunteers welcome
- Sponsor
- Hospital Universitario Pedro Ernesto
Sepsis, Length of Stay
Limited Versus Extended Trophic Feeding (LET-FEED) Trial
Study Hypothesis/Question In infants born very preterm, advancing enteral feeds after 24 hours from birth (limited trophic feeds) versus after 72 hours (extended trophic feeds) reduces the risk of all-cause late onset sepsis…
- Conditions
- Sepsis, Length of Stay, Mortality, Neurodevelopmental Delay
- Trial name
- LET-FEED (NCT06893939)
- Testing
- Limited Trophic Feeds (1 day of trophic feeds), Extended Trophic Feeds (3 days of trophics)
- Where
- 6 sites in United States
- Volunteers
- 350 people, healthy volunteers welcome
- Sponsor
- University of Washington
Very Low Birth Weight Infants
Early Family Based Intervention in Preterm Infants
This is randomized controlled trial investigating the effect of early intervention in very low birth weight infants after discharge from NICU on neurodevelopmental outcome.
- Trial name
- NCT02415530
- Testing
- Combined home visiting and group intervention, No intervention
- Where
- 3 sites in South Korea
- Volunteers
- 150 people, healthy volunteers welcome
- Sponsor
- Seoul National University Hospital
Influenza
Study of Live, Attenuated Influenza Vaccination in Preterm and Full-Term Infants
Severe influenza respiratory disease is increasingly recognized in children. Influenza hospitalization rates in high-risk infants, such as premature infants, are increased some five-fold over rates in other children.
- Trial name
- NCT01194297
- Testing
- Live attenuated influenza vaccine, Inactivated influenza vaccine
- Volunteers
- 3 people, healthy volunteers welcome
- Sponsor
- University of Rochester
Very Preterm Infant, Very Low Birth Weight Infants
The Use of Early Fortification in Preterm Infants
Very premature or very low birth weight (VLBW) infants are at risk of suboptimal growth after birth, making adequate nutrition essential.
- Trial name
- NCT07861984
- Testing
- Early Fortification, Standard Fortification
- Where
- Indonesia
- Volunteers
- 44 people, healthy volunteers welcome
- Sponsor
- Universitas Indonesia
Temperature Regulation; Disorder, Fetus or Newborn
Effect of Drying Before Plastic Wrapping on Thermal Losses in Very Preterm Infants at Birth
This is a multicenter, unblinded, randomized controlled trial comparing drying vs. not drying before plastic wrapping for the thermoregulation of very preterm infants at birth.
- Trial name
- NEODRY (NCT05740072)
- Testing
- Drying before wrapping, No drying before wrapping
- Where
- Italy
- Volunteers
- 346 people, healthy volunteers welcome
- Sponsor
- University Hospital Padova