Clinical trials: Prematurity; Extreme
Low Birth Weight, Prematurity
The Impact of Extreme Environmental and Security Conditions on Prematurity and Low Birth Weight Rates
Numerous reports indicate that various extreme environmental and security-related situations during pregnancy may increase the risk of prematurity, LBW, and miscarriage, as these events increase both the incidence and intensity…
- Trial name
- NCT07531134
- Testing
- No intervention
- Where
- Israel
- Volunteers
- 100,000 people, healthy volunteers welcome
- Sponsor
- Hillel Yaffe Medical Center
Pregnancy Complications, Maternal Death
Nutrition Optimalization Among Pregnant Women to Improve Maternal and Neonatal Outcome in DKI Jakarta
The goal of this MONAS Study is to learn about comprehensive monitoring and nutritional intervention among pregnant women in order to improve maternal and neonatal outcomes. The main questions it aims to answer are: 1.
- Conditions
- Pregnancy Complications, Maternal Death, Preeclampsia, Intrauterine Infection
- Trial name
- MONAS (NCT06268509)
- Testing
- Nutritional panel laboratory examination, Pregnancy supplements (other than provided by Ministry of Health), Fetomaternal ultrasound
- Where
- Indonesia
- Volunteers
- 245 people
- Sponsor
- Dr Cipto Mangunkusumo General Hospital
Respiratory Distress Syndrome (RDS), Bronchopulmonary Dysplasia (BPD)
Can Betamethasone Given After Birth Help Extremely Premature Babies Come Off Breathing Support Safely and Effectively?
The goal of this study is to determine if giving a steroid medication (specifically, betamethasone) after birth can help extremely premature babies (born before 28 weeks) come off breathing machines safely and reduce their risk…
- Trial name
- NCT07447739
- Testing
- Betamethasone
- Where
- United States
- Volunteers
- 100 people
- Sponsor
- Khang Nguyen
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
Fluid Loss, Dehydration
The Application of Sterile Water to the Skin of Extremely Low Birth Weight (ELBW) Infants
Extremely low birth weight infants have significant water loss through their skin immediately after birth. This significant fluid loss is because they have large amounts of fluids, have immature skin and large surface area.
- Conditions
- Fluid Loss, Dehydration, Extreme Immaturity
- Trial name
- NCT02052284
- Testing
- Sterile water application
- Where
- United States
- Volunteers
- 30 people
- Sponsor
- George Washington University
Extreme Immaturity
Sodium Supplementation and Growth in Very Low Birth Weight Infants
Adequate growth during the neonatal period is critical for optimal long term outcomes. Despite maximal calorie intake, sixty percent of very low birth weight infants still fail to thrive suggesting that factors other than total…
- Trial name
- SSALT (NCT01795638)
- Testing
- Sodium chloride
- Where
- United States
- Volunteers
- 53 people
- Sponsor
- Children's Hospital Medical Center, Cincinnati
Infant, Premature, Respiratory Disease
Extremely Preterm Respiratory Outcome Cohort
This study examines the respiratory outcomes of preterm infants born at gestational ages less than 29 weeks, spanning from birth to 24 months corrected age.
- Trial name
- NCT06726226
- Testing
- Standard care for preterm infants
- Where
- South Korea
- Volunteers
- 600 people, healthy volunteers welcome
- Sponsor
- Seoul National University Hospital
Infant, Newborn, Infant, Low Birth Weight
Exosurf Neonatal and Survanta for Treatment of Respiratory Distress Syndrome
The purpose of this study is to compare the efficacy of two surfactants, Exosurf Neonatal (Burroughs Wellcome Co.) and Survanta (Ross Laboratories), for the treatment of neonatal respiratory distress syndrome.
- Conditions
- Infant, Newborn, Infant, Low Birth Weight, Infant, Small for Gestational Age, Infant, Premature
- Trial name
- Surfactant 1 (NCT01203358)
- Testing
- Exosurf, Survanta
- Where
- 13 sites in United States
- Volunteers
- 617 people
- Sponsor
- NICHD Neonatal Research Network
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
Bronchopulmonary Dysplasia
Use of Human Milk Cream to Decrease Length of Stay in Extremely Premature Infants
At present, widespread use of the human milk-based caloric supplement (cream) has not occurred, particularly in infants with bronchopulmonary dysplasia (BPD), and further data are needed to support its adoption as a standard care…
- Trial name
- NCT02475434
- Testing
- Cream Supplement group
- Where
- 8 sites in United States, Austria
- Volunteers
- 210 people
- Sponsor
- Baylor College of Medicine
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
Brain Injuries, Congenital Heart Disease
Protecting Brains and Saving Futures - the PBSF Protocol
Background: Multiple neonatal disorders are associated with risks of neurological injury. Thus, management of these infants should involve a coordinated approach to permit early diagnosis with improved clinical care.
- Conditions
- Brain Injuries, Congenital Heart Disease, Newborn Morbidity, Intraventricular Hemorrhage
- Trial name
- PBSF (NCT03786497)
- Where
- 2 sites in Brazil
- Volunteers
- 2,268 people
- Sponsor
- Protecting Brains Saving Futures
Prematurity; Extreme
A Study of Factors Associated With Failure of the Golden Hour Protocol in the Initial Care of Extremely Preterm and Very Low Birth Weight Newborns
Preterm infants are a particularly vulnerable population, especially during the first hours of life as they adapt to life outside the womb.
- Trial name
- PREM-GH (NCT07829562)
- Testing
- Golden hour
- Where
- France
- Volunteers
- 50 people
- Sponsor
- Centre Hospitalier Universitaire de Nice
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
Infant, Extremely Premature, Brain Injuries
Safeguarding the Brain of Our Smallest Infants Phase III
the SafeBoosC-III trial investigates the benefit and harms of treatment based on near-infrared spectroscopy monitoring compared with treatment as usual.
- Conditions
- Infant, Extremely Premature, Brain Injuries, Death, Brain, Death; Neonatal
- Trial name
- SafeBoosC (NCT03770741)
- Testing
- Modify cardio-respiratory support to avoid cerebral hypoxia, Treatment as usual
- Where
- Denmark
- Volunteers
- 1,601 people
- Sponsor
- Gorm Greisen
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
Retinopathy of Prematurity (ROP), Intraventricular Hemorrhage
Safety and Efficacy Outcomes Following Previously Administered Short-Term Treatment With SHP607 in Extremely Premature Infants
The purpose of this study is to evaluate long-term safety and efficacy outcomes following previously administered short-term exposure to SHP607, as compared to a standard neonatal care group.
- Conditions
- Retinopathy of Prematurity (ROP), Intraventricular Hemorrhage, Bronchopulmonary Dysplasia, Chronic Lung Disease of Prematurity
- Trial name
- NCT04506619
- Testing
- No Intervention
- Where
- 8 sites in United States, Italy and 1 more
- Volunteers
- 26 people
- Sponsor
- Oak Hill Bio Ltd
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
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
Prematurity; Extreme, Feeding Difficulties
Cot-side Suckometry and Oral Stimulation in Very Preterm Infants: A Pilot Study
Very preterm infants - born before 32 weeks' gestational age - commonly experience delayed transition to oral feeding due to immature suck-swallow-breathe coordination.
- Trial name
- STIMPREM (NCT07632066)
- Testing
- Bedside Suckometer, Structured Oral Stimulation Protocol
- Where
- France
- Volunteers
- 17 people
- Sponsor
- Hôpital de la Croix-Rousse