Clinical trials: Infant, Extremely Premature
Bronchopulmonary Dysplasia, Prematurity
Impact of Extended CPAP on Bronchopulmonary Dysplasia
The purpose of this pilot study is to compare if keeping infants on CPAP (continuous positive airway pressure) support for an extended period of time until they are 32 weeks corrected gestational age or 1250 grams (approximately…
- Trial name
- NCT05547139
- Testing
- Protocolized weaning of respiratory support
- Where
- United States
- Volunteers
- 20 people, healthy volunteers welcome
- Sponsor
- Christiana Care Health Services
Infant, Newborn, Infant, Low Birth Weight
Multi-dose Pharmacokinetics and Dose Ranging of Inositol in Premature Infants (INS-2)
This pilot study is a randomized, placebo-controlled, clinical trial to measure changes in blood and urine levels of inositol in premature infants at high risk for retinopathy of prematurity (ROP) following repeated doses of…
- Conditions
- Infant, Newborn, Infant, Low Birth Weight, Infant, Small for Gestational Age, Infant, Premature
- Trial name
- INS-2 (NCT01030575)
- Testing
- Inositol lower volume, Inositol mid-level volume, Inositol high volume
- Where
- 17 sites in United States
- Volunteers
- 125 people, healthy volunteers welcome
- Sponsor
- NICHD Neonatal Research Network
Prematurity; Extreme
Pulmonary Vascular Disease and Cardiac Performance in Extreme Preterm Infants
Pulmonary vascular disease and cardiac performance in extreme preterm infants: A prospective cross-sectional study
- Trial name
- NCT04114435
- Testing
- Echocardiography
- Where
- Canada
- Volunteers
- 150 people, healthy volunteers welcome
- Sponsor
- McGill University Health Centre/Research Institute of the McGill University Health Centre
Bronchopulmonary Dysplasia
Early Predictors of Bronchopulmonary Dysplasia in Extremely Preterm Infants
Bronchopulmonary dysplasia (BPD) remains one of the most common complications in extremely preterm infants despite advances in neonatal intensive care.
- Trial name
- EPIRESP (NCT07771387)
- Where
- Austria
- Volunteers
- 140 people, healthy volunteers welcome
- Sponsor
- Medical University of Vienna
Caregiver Feeling
Feeling of Caregivers After a Palliative Management of Extreme Premature Babies in Delivery Room.
Introduction : The birth of a child is usually a happy event that caregivers working in delivery rooms share with families. Unfortunately, newborns sometimes need palliative care as soon as birth occurs.
- Trial name
- NCT06458114
- Testing
- Assessment of caregiver feeling
- Where
- France
- Volunteers
- 50 people, healthy volunteers welcome
- Sponsor
- CHU de Reims
Preterm, Very Low Birth Weight Infant
Weight Gain in Extremely Premature Infant With Targeted Versus Adjusted Fortification
Investigation about the effect on weight gain in extremely low birth weight preterm with individualized fortification, according to human milk analysis versus fortification adjusted according to urea serum concentration.
- Conditions
- Preterm, Very Low Birth Weight Infant, Feeding, Breast, Food, Fortified
- Trial name
- FORTIN (NCT04982133)
- Testing
- Protein supplementation based on plasma urea concentration every other week or human milk analysis on experiment
- Where
- Spain
- Volunteers
- 38 people, healthy volunteers welcome
- Sponsor
- Hospital Universitario La Paz
Premature Birth, Extremely Premature Infants
Prenatal Counseling in Extreme Prematurity: Professionals' View
This study is part of the PreCo study, evaluating Dutch care in (imminent) extreme preterm birth including current and preferred counseling, barriers and facilitators for preferred counseling from both obstetricians and…
- Trial name
- PreCo-profs (NCT02782650)
- Testing
- survey and interview
- Volunteers
- 122 people, healthy volunteers welcome
- Sponsor
- Radboud University Medical Center
Bronchopulmonary Dysplasia, Death
Systemic Management in Extremely Preterm and Extremely Low Birth Weight Infants
to estimate incidences of major complications, such as bronchopulmonary dysplasia, death, and delivery room resuscitation among extremely preterm and extremely low birth weight infants in Northern China
- Trial name
- NCT06082414
- Testing
- no interventions
- Where
- China
- Volunteers
- 1,200 people, healthy volunteers welcome
- Sponsor
- Peking University
Infant, Newborn, Infant, Low Birth Weight
The Effects of Erythropoietin (EPO) on the Transfusion Requirements of Very Low Birth Weight Infants
This study tested the safety and efficacy of transfusing erythropoietin (Epo) and iron in infants of <1,250g birth weight. For infants 401-1,000g birth weight, we tested whether early erythropoietin (Epo) and iron therapy would…
- Conditions
- Infant, Newborn, Infant, Low Birth Weight, Infant, Small for Gestational Age, Infant, Premature
- Trial name
- EPO (NCT01203514)
- Testing
- Erythropoietin
- Where
- 9 sites in United States
- Volunteers
- 318 people, healthy volunteers welcome
- 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
Infant, Newborn, Infant, Low Birth Weight
Benchmarking Initiative to Reduce Bronchopulmonary Dysplasia
This study tested whether Neonatal Intensive Care Unit (NICU) teams trained in benchmarking -- comparing care practices between different NICUs to see which practices prevent bronchopulmonary dysplasia (BPD) -- and quality…
- Conditions
- Infant, Newborn, Infant, Low Birth Weight, Infant, Small for Gestational Age, Infant, Premature
- Trial name
- Benchmarking (NCT00067613)
- Testing
- Benchmarking Management Practices, Standard Management Practices
- Where
- 17 sites in United States
- Volunteers
- 4,095 people, healthy volunteers welcome
- Sponsor
- NICHD Neonatal Research Network
Parent-Child Relations, Parents
Therapist Education and Massage for Parent Infant-Outcomes
The Therapist Education and Massage for Parent-Infant Outcomes program is evidence-based and includes infant massage, physical therapy interventions including developmental support and play activities to promote infant…
- Conditions
- Parent-Child Relations, Parents, Extreme Prematurity
- Trial name
- TEMPO (NCT04121897)
- Testing
- Therapist Education and Massage for Parents of Extremely Preterm Infants
- Where
- United States
- Volunteers
- 68 people, healthy volunteers welcome
- Sponsor
- University of North Carolina, Chapel Hill
Premature Infants, Cerebral Palsy
Interrater Reliability of Infant Motor Profile
The aim of this study is to assess risky infants (or diagnosed infants) with Infant Motor Profile, and analyze interrater and intrarater reliability of this test.
- Conditions
- Premature Infants, Cerebral Palsy, Down Syndrome, Metabolic Disorders
- Trial name
- IMP (NCT03188107)
- Testing
- Video based assessment
- Volunteers
- 50 people, healthy volunteers welcome
- Sponsor
- Abant Izzet Baysal University
Infant, Extremely Premature, Length of Stay
Trial of Patterned Oral Somatosensory Entrainment for Shortening Time to Oral Feeding
The primary hypothesis is that the preterm infants (26 0/7 to 30 6/7 weeks gestational age) who undergo the NTrainer System® training will transition to full oral feeds faster than the control group (i.e.
- Conditions
- Infant, Extremely Premature, Length of Stay, Feeding
- Trial name
- NCT01158391
- Testing
- NTrainer® Intervention, Control Intervention
- Where
- 5 sites in United States
- Volunteers
- 210 people, healthy volunteers welcome
- Sponsor
- KC BioMediX, Inc
Infant, Newborn, Infant, Small for Gestational Age
Vitamin E for Extremely Preterm Infants
The purpose of this pilot trial is to test the safety and efficacy of administering one dose of vitamin E, via a tube into the stomach, to extremely preterm infants (less than 27 weeks gestation and less than 1000 grams birth…
- Conditions
- Infant, Newborn, Infant, Small for Gestational Age, Infant, Very Low Birth Weight, Infant, Premature
- Trial name
- NCT01193270
- Testing
- Vitamin E
- Where
- 16 sites in United States
- Volunteers
- 93 people, healthy volunteers welcome
- Sponsor
- NICHD Neonatal Research Network
Premature Infants
Targeted Protein Fortification in Extremely Low Birth Weight Preterm Infants
While new innovations in the care of extremely premature infants have led to decreased morbidity and mortality, poor postnatal growth remains as a major challenge.
- Trial name
- NCT02943746
- Testing
- Standard Protein Diet, High Protein Diet
- Where
- United States
- Volunteers
- 118 people, healthy volunteers welcome
- Sponsor
- Baylor College of Medicine
Infant, Newborn, Infant, Low Birth Weight
Inflammatory Cytokines Associated With Perinatal Brain Injury
This observational study assessed whether measurements of certain pro-inflammatory and anti-inflammatory cytokines in the blood (either singly or in combination) at birth and/or up to day of life 21 can predict cerebral palsy at…
- Conditions
- Infant, Newborn, Infant, Low Birth Weight, Infant, Small for Gestational Age, Infant, Premature
- Trial name
- Cytokines (NCT01035697)
- Where
- 18 sites in United States
- Volunteers
- 1,067 people, healthy volunteers welcome
- Sponsor
- NICHD Neonatal Research Network
Premature, Extremely Low Birth Weight Infants, Polyunsaturated Fatty Acid Levels
PUFA Supplementation in Premature Infants
The purpose of this study is to determine if buccal administration of a concentrated formulation of long-chain polyunsaturated fatty acids (LCPUFA) can help to maintain docosahexaenoic acid (DHA) levels in extremely low birth…
- Trial name
- NCT01955044
- Testing
- LCPUFA supplement
- Where
- 3 sites in United States
- Volunteers
- 30 people, healthy volunteers welcome
- Sponsor
- Endeavor Health
Infant, Newborn, Infant, Low Birth Weight
In Utero Magnesium Sulfate Exposure: Effects on Extremely-Low-Birth-Weight Infants
This study examined the effect of magnesium sulfate (MgSO4) exposure on adverse outcome in extremely low birth weight (ELBW) infants.
- Conditions
- Infant, Newborn, Infant, Low Birth Weight, Infant, Small for Gestational Age, Infant, Premature
- Trial name
- MgSO4 (NCT01203501)
- Where
- 15 sites in United States
- Volunteers
- 1,339 people, healthy volunteers welcome
- Sponsor
- NICHD Neonatal Research Network
Pneumococcal Infections, Streptococcus Pneumoniae
Immunogenicity of PCV-7 Vaccine in VLBW Infants
Premature infants are at a high risk for pneumonia. The PCV-7 vaccine effectively prevents the invasive disease from Streptococcus pneumoniae in full-term infants, but was not thoroughly studied in premature infants.
- Conditions
- Pneumococcal Infections, Streptococcus Pneumoniae, Infant, Newborn, Infant, Low Birth Weight
- Trial name
- PCV-7 (NCT00273325)
- Where
- 10 sites in United States
- Volunteers
- 368 people, healthy volunteers welcome
- Sponsor
- NICHD Neonatal Research Network