Clinical trials: Low Birth Weight Infant
Infant, Very Low Birth Weight, Growth Failure
Preterm Infants on Early Solid Foods
Introduction: Preterm infants with a birth weight less than 1500 grams have special nutritional needs in comparison to full-term neonates.
- Trial name
- PIES-Project (NCT01809548)
- Testing
- Early intervention group, Late intervention group
- Where
- Austria
- Volunteers
- 177 people
- Sponsor
- Medical University of Vienna
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
Infant, Low Birth Weight
Household Air Pollution and Health: A Multi-country LPG Intervention Trial
This study is a randomized controlled trial of liquefied petroleum gas (LPG) stove and fuel distribution in 3,200 households in four countries (India, Guatemala, Peru, and Rwanda).
- Trial name
- HAPIN (NCT02944682)
- Testing
- Liquefied petroleum gas (LPG) cookstove
- Where
- 4 sites in Guatemala, India and 2 more
- Volunteers
- 6,704 people
- Sponsor
- Emory University
Premature Birth, Growth Failure
Predictors of Postnatal Growth Failure in Preterm Infants
This prospective observational study aims to identify the clinical and nutritional predictors of postnatal growth failure among preterm infants admitted to the Neonatal Intensive Care Unit of Assiut University Children's Hospital.
- Conditions
- Premature Birth, Growth Failure, Very Low Birth Weight Infant
- Trial name
- NCT07818681
- Volunteers
- 120 people
- Sponsor
- Assiut University
Infant, Very Low Birth Weight, Infant Development
Cue-Based Vs. Clinician-Driven Feeding in Very Low Birthweight Infants
In this parallel-group randomized controlled trial, very low birthweight infants will be randomly assigned in a 1:1 ratio to either cue-based (intervention group) or clinician-driven feeding (control group).
- Conditions
- Infant, Very Low Birth Weight, Infant Development, Feeding Patterns
- Trial name
- NCT06569186
- Testing
- Cue-based feedings
- Where
- United States
- Volunteers
- healthy volunteers welcome
- Sponsor
- University of Alabama at Birmingham
Infant, Newborn, Infant, Small for Gestational Age
Donor Milk vs. Formula in Extremely Low Birth Weight (ELBW) Infants
The Milk Trial seeks to determine the effect on neurodevelopmental outcomes at age 22-26 months of donor human milk as compared to preterm infant formula as the in-hospital diet for infants whose mothers choose not to provide…
- Conditions
- Infant, Newborn, Infant, Small for Gestational Age, Infant, Extremely Low Birth Weight
- Trial name
- NCT01534481
- Testing
- Donor Milk, Preterm Formula
- Where
- 17 sites in United States
- Volunteers
- 483 people
- Sponsor
- NICHD Neonatal Research Network
Infant, Newborn, Infant, Low Birth Weight
Follow-up Visit of High Risk Infants
The NICHD Neonatal Research Network's Follow-Up study is a multi-center cohort in which surviving extremely low birth-weight infants born in participating network centers receive neurodevelopmental, neurosensory and functional…
- Conditions
- Infant, Newborn, Infant, Low Birth Weight, Infant, Small for Gestational Age, Infant, Premature
- Trial name
- FU (NCT00009633)
- Testing
- No Intervention
- Where
- 31 sites in United States
- Volunteers
- 68,000 people
- Sponsor
- NICHD Neonatal Research Network
Infant, Newborn, Infant, Low Birth Weight
Delivery Room CPAP in Extremely Low Birth Weight Infants
This pilot study was designed to determine the feasibility of randomizing extremely low birth weight (ELBW) infants <28 weeks' gestation who required resuscitation to one of two resuscitation methods, either: (a) 100% oxygen by…
- Conditions
- Infant, Newborn, Infant, Low Birth Weight, Infant, Small for Gestational Age, Infant, Premature
- Trial name
- DR-CPAP (NCT01223274)
- Testing
- CPAP/PEEP, Standard management practices
- Where
- 6 sites in United States
- Volunteers
- 104 people
- Sponsor
- NICHD Neonatal Research Network
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
Neonatal Respiratory Distress, Very Low Birth Weight Infant
PRICO: OPTI Target Range
The aim of the study is to determine if a narrower SpO2 Target Range setting automated control of FiO2 (A-FiO2) is more effective than a wider SpO2 Target Range
- Trial name
- POSTR (NCT06207994)
- Testing
- Narrow TR, Shifted TR
- Where
- Czechia
- Volunteers
- 11 people
- Sponsor
- Czech Technical University in Prague
Very Low Birth Weight Infant
Individualized Fortification of Human Milk for Infants Born ≤ 1250 g (MaxiMoM-InForM)
Very low birth weight infants have increased nutritional needs. Extra nutrients are added to their human milk feeds to help improve their nutritional status, growth and neurodevelopment.
- Trial name
- NCT05308134
- Testing
- Standard fortification, Target fortification, BUN adjustable fortification
- Where
- 20 sites in Canada
- Volunteers
- 615 people
- Sponsor
- The Hospital for Sick Children
Bacteremia, Infant, Very Low Birth Weight
Preventing Catheter-related Bacteremia When Administering Injectable Medications in Premature Infants.
This study evaluates the potential interest of a new multi-lumen infusion access device (Edelvaiss® Multiline NEO) in the prevention of catheter-related bacteremia when administering injectable drugs in premature infants.
- Trial name
- MultilineNEO (NCT02633124)
- Testing
- Edelvaiss Multiline NEO, Standard Infusion Set
- Where
- 4 sites in France
- Volunteers
- 87 people, healthy volunteers welcome
- Sponsor
- University Hospital, Lille
Extremely Low Birth Weight Infants
Post-Extubation Assessment of Clinical Stability in ELBW Infants
This is an observational, proof-of-concept, feasibility study that aims to evaluate the feasibility of a monitoring system that integrates clinical data, high-resolution waveforms from the bedside monitor, regional oxygenation…
- Trial name
- PEACE (NCT06037083)
- Testing
- Oxygen saturation probe, Near infrared spectroscopy sensors, Electrical impedance tomography
- Where
- 2 sites in Canada
- Volunteers
- 20 people
- Sponsor
- McGill University Health Centre/Research Institute of the McGill University Health Centre
Thrombocytopenia, Neonatal
Neonatal Platelet Transfusion Threshold Trial
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…
- Conditions
- Thrombocytopenia, Neonatal, Platelet Transfusion, Infant, Newborn, Diseases
- Trial name
- NeoPlaTT (NCT06676904)
- Testing
- Higher Platelet Transfusion Threshold, Lower Platelet Transfusion Threshold
- Where
- 20 sites in United States
- Volunteers
- 2,433 people, healthy volunteers welcome
- Sponsor
- NICHD Neonatal Research Network
BPD - Bronchopulmonary Dysplasia, VLBW - Very Low Birth Weight Infant
Duodenal Feeds in Very Low Birth Weight Infants
Premature infants have high rates of bronchopulmonary dysplasia (BPD) due to prematurity of the participants' lungs and the need for prolonged respiratory support.
- Conditions
- BPD - Bronchopulmonary Dysplasia, VLBW - Very Low Birth Weight Infant, Feeding Disorder Neonatal, Feeding; Difficult, Newborn
- Trial name
- NCT04246333
- Testing
- Mode of Delivery of Feeds
- Where
- United States
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- Johns Hopkins All Children's Hospital
Infant, Newborn, Infant, Low Birth Weight
Generic Database of Very Low Birth Weight Infants
The Generic Database (GDB) is a registry of very low birth weight infants born alive in NICHD Neonatal Research Network (NRN) centers.
- Conditions
- Infant, Newborn, Infant, Low Birth Weight, Infant, Small for Gestational Age, Infant, Premature
- Trial name
- GDB (NCT00063063)
- Testing
- No Intervention
- Where
- 31 sites in United States
- Volunteers
- 80,000 people
- Sponsor
- NICHD Neonatal Research Network
Low Birth Weight, Premature Birth
Comparison of Outcomes of Early Kangaroo Mother Care and Standard Method Care in Healthy Low Birth Weight Preterm Neonates at a Tertiary Care Hospital
The goal of this clinical trial is to learn whether early initiation of kangaroo mother care (KMC) can improve clinical outcomes in healthy low birth weight preterm neonates (gestational age 30-37 weeks, birth weight <2000 g).
- Conditions
- Low Birth Weight, Premature Birth, Preterm Infant
- Trial name
- NCT07259486
- Testing
- Kangaroo Mother Care, Standard Medical Care (SMC)
- Where
- Pakistan
- Volunteers
- 100 people
- Sponsor
- University of Health Sciences Lahore
Infant, Extremely Low Birth Weight, Feeding Behavior
Somatosensory Modulation of Salivary Gene Expression and Oral Feeding in Preterm Infants
Two innovative approaches, pulsatile orocutaneous entrainment of non-nutritive suck via orosensory entrainment (NTrainer) device technology and serial salivary gene expression analyses, will be merged to examine the relation…
- Trial name
- NCT02696343
- Testing
- NTrainer
- Where
- 4 sites in United States
- Volunteers
- 121 people
- Sponsor
- University of Nebraska Lincoln
Pumping, Breast, Milk, Human
Reducing Disparity in Receipt of Mother's Own Milk in Very Low Birth Weight Infants
In the US, the burden of very low birth weight (VLBW; <1500 g) birth is borne disproportionately by black (non-Hispanic black/African American) mothers who are 2.2-2.6 times more likely than nonblack mothers to deliver VLBW…
- Conditions
- Pumping, Breast, Milk, Human, Infant, Very Low Birth Weight, Preterm Birth
- Trial name
- ReDiMOM (NCT04540575)
- Testing
- NICU Acquires MOM, Mother Provides MOM
- Where
- United States
- Volunteers
- 362 people
- Sponsor
- Rush University Medical Center
Infant, Very Low Birth Weight
Quality Improvement Project - Evaluation of Current Standard of Care for Feeding Practices in the NICU
Human milk is associated with substantial benefits to infants' health and development, especially in premature infants. Some mothers are unable or unwilling to provide breast milk to their infant.
- Trial name
- NICU (NCT01204983)
- Where
- United States
- Volunteers
- 150 people
- Sponsor
- Baylor College of Medicine