Clinical trials: Low-Birth-Weight
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
Well-Being, Psychological, Breastfeeding
Relaxation Intervention to Improve Newborn Growth and Maternal Well-being
The goal of this clinical trial is to learn if listening to a relaxation audiorecording during breastfeeding improves breastfeeding and infant outcomes and maternal well-being in a low-income country setting.
- Conditions
- Well-Being, Psychological, Breastfeeding, Low Birth Weight, Undernutrition
- Trial name
- RING-MW (NCT07774793)
- Testing
- Relaxation audiorecording, Control audio device without relaxation audiorecording
- Where
- Uganda
- Volunteers
- 100 people
- Sponsor
- University of California, San Francisco
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
Prematurity, Low Birth Weight
Paternal Involvement in Nursing Guidance and Breastfeeding Self-Efficacy in Mothers of High-Risk Newborns
This study aims to evaluate whether a structured nursing guidance program that increases fathers' participation in the care of hospitalized high-risk newborns improves maternal outcomes compared with routine nursing care.
- Conditions
- Prematurity, Low Birth Weight, Respiratory Distress Syndrome, Newborn, Neonatal Hyperbilirubinemia
- Trial name
- NCT07834008
- Testing
- step-by-step parent education, active father participation in breastfeeding support
- Where
- Taiwan
- Volunteers
- 80 people, healthy volunteers welcome
- Sponsor
- Taipei Medical University Shuang Ho Hospital
Low Birth Weight, Kangaroo Mother Care
Admission to Kangaroo Mother Care (KMC) Ward and Maternal Postpartum Depression
The goal of this clinical trial is to learn if extended admission to the Kangaroo Mother Care (KMC) ward helps to prevent postpartum depression in mothers of low birthweight infants in a low-resource setting whose newborns were…
- Conditions
- Low Birth Weight, Kangaroo Mother Care, Postpartum Depression, Neurodevelopmental Outcome
- Trial name
- KMC PPD (NCT06545760)
- Testing
- Kangaroo mother care (KMC) support for > 2 days, Kangaroo mother care (KMC) support for < 2 days
- Where
- Zambia
- Volunteers
- 1,908 people
- Sponsor
- University of Alabama at Birmingham
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
Prematurity of Fetus, Low Birth Weight Baby
Daily Skin-to-Skin Contact Duration in Preterm and Low Birth Weight Infants Admitted to a Kangaroo Care Unit
Kangaroo Mother Care promotes prolonged skin-to-skin contact between newborns and their parents. Although this practice is routinely encouraged in Kangaroo Care Units, the daily duration of skin-to-skin contact varies…
- Trial name
- PAP-UK (NCT07747870)
- Where
- France
- Volunteers
- 240 people
- Sponsor
- Centre Hospitalier de Valenciennes
Low Birth Weight Among Neonates
EFFECT OF KANGAROO MOTHER CARE ON HOSPITAL OUTCOME IN LOW BIRTH WEIGHT
Kangaroo Mother Care is a novel intervention known to improve survival, nutrition and prevent infections. Kangaroo Mother Care encompasses prolonged skin-to-skin contact between the mother and the baby and exclusive breastfeeding…
- Trial name
- NCT07736274
- Testing
- Kangaroo Mother Care, Conventional Neonatal Care
- Where
- Pakistan
- Volunteers
- 100 people
- Sponsor
- Pakistan Navy Station Shifa Hospital
Maternal Micronutrient Status, Pregnancy
Multiple Micronutrient Versus Iron-Folic Acid Supplementation in Pregnant Women in Indonesia
Micronutrient deficiencies during pregnancy may affect the mother's nutritional status and the baby's growth. This study compared two types of daily supplements for pregnant women: a multiple micronutrient supplement and an iron…
- Conditions
- Maternal Micronutrient Status, Pregnancy, Low Birth Weight, Maternal Anemia
- Trial name
- NCT07725549
- Testing
- Multiple micronutrient supplementation, Iron and Folic Acid Supplementation
- Where
- Indonesia
- Volunteers
- 66 people
- Sponsor
- Indonesia Timur University
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
Preterm Birth, Low Birth Weight
Periodontal Disease and Small Vulnerable Newborns in Rural Nepal: A Community-based Trial
Periodontal disease in pregnant women has been implicated as a potential risk factor for adverse pregnancy outcomes, including being born preterm, small-for-gestational age, and/or low birth weight.
- Conditions
- Preterm Birth, Low Birth Weight, Small Vulnerable Newborn, Small-for-gestational Age
- Trial name
- NCT07553286
- Testing
- A package of oral health interventions, including a daily antiseptic oral rinse (alcohol-free cetylpyridinium chloride (0.075%))
- Volunteers
- 2,280 people, healthy volunteers welcome
- Sponsor
- Johns Hopkins Bloomberg School of Public Health
Fetal Growth Retardation, Low Birth Weight
BEP Supplementation Research in Bangladesh (JiVitA-BEP-IR)
The primary aim of the study is to evaluate the effect of fortified balanced energy and protein (BEP) supplementation vs. control (multiple micronutrient supplement, MMS) without targeting and with targeting (either by low…
- Conditions
- Fetal Growth Retardation, Low Birth Weight, Preterm Birth, Gestational Weight Gain
- Trial name
- Target-BEP (NCT05576207)
- Testing
- Balanced energy and protein supplement for pregnant women, Multiple Micronutrient Supplement for pregnant women
- Where
- Bangladesh
- Volunteers
- 3,390 people, healthy volunteers welcome
- Sponsor
- Johns Hopkins Bloomberg School of Public Health
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
Non-Alcoholic Fatty Liver Disease, Low Birth Weight
Increased Risk of Non-alcoholic Fatty Liver Disease in Low Birth Weight Individuals
The investigators recently demonstrated a increase in liver fat in early middle-aged LBW compared to normal birth weight (NBW) men, and 20% of the LBW - but none of the normal birth weight (NBW) - men had previously unknown…
- Trial name
- NCT05890365
- Where
- Denmark
- Volunteers
- 300 people
- Sponsor
- Steno Diabetes Center Copenhagen
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