Clinical trials: Prematurity; Extreme
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
Chickenpox, Rubella
MMR and Varicella Vaccine in Premature Infants
This research is designed to address the question, "Does the relative deficit in vaccine immunogenicity in extremely premature infants persist beyond the first 6 months of life?" We propose to measure the immunogenicity of…
- Conditions
- Chickenpox, Rubella, Rubeola, Mumps
- Trial name
- NCT00156559
- Where
- United States
- Volunteers
- 32 people, healthy volunteers welcome
- Sponsor
- University of Rochester
Extremely Low Gestational Age Newborn, Premature Infant
Oropharyngeal Administration of Colostrum to Extremely Low Gestational Age Newborns
Colostrum is rich in cytokines and other immune agents that may provide immunomodulatory protection against nosocomial infection in extremely premature infants.
- Trial name
- NCT01536093
- Testing
- oropharyngeal administration of own mother's colostrum, oropharyngeal administration of sterile water
- Where
- South Korea
- Volunteers
- 48 people, healthy volunteers welcome
- Sponsor
- Seoul National University Hospital
Infant, Newborn, Infant, Low Birth Weight
Antenatal Phenobarbital to Prevent Neonatal Intracranial Hemorrhage
This large randomized trial tested whether phenobarbital given to a pregnant woman about to deliver a premature infant would prevent brain injuries in their newborns.
- Conditions
- Infant, Newborn, Infant, Low Birth Weight, Infant, Small for Gestational Age, Infant, Premature
- Trial name
- Phenobarbital (NCT00009620)
- Testing
- Phenobarbital, Saline
- Where
- 11 sites in United States
- Volunteers
- 610 people, healthy volunteers welcome
- Sponsor
- NICHD Neonatal Research Network
Transient Hypothyroxinemia of Prematurity (THOP)
Study of Thyroid Hormones in Prematures
The investigators hypothesize that continuous infusion of 4 µg/Kg/day T4 with 30 µg/Kg/day oral potassium iodide (KI) for 42 days from birth will reduce by 30% or more (from an estimated 30% to 21%) the proportion of extremely…
- Trial name
- THOP2 (NCT02103998)
- Testing
- thryoid hormone T4 + oral potassium iodide (KI) for 42 days, D5W - 5% dextrose water
- Where
- United States
- Volunteers
- healthy volunteers welcome
- Sponsor
- New York Medical College
Retinopathy of Prematurity
Effects of Early Vitamin A Supplementation on the Risk for Retinopathy of Prematurity in Extremely Preterm Infants
Retinopathy of prematurity (ROP) is a common retinal neovascular disorder and major cause of vision impairment or blindness, despite current treatment of late stage ROP.
- Trial name
- NCT03154723
- Testing
- Vitamin A
- Where
- China
- Volunteers
- 262 people, healthy volunteers welcome
- Sponsor
- Huiqing Sun
Extremely Premature Newborn (Born Before 32 Weeks' Gestation)
Description of Changes in NIRS as a Function of Ductus Arteriosus Status in Very Premature Babies Born Before 32 WG at the DIJON University Hospital
Monitoring patent ductus arteriosus is currently performed using echocardiography, an operator-dependent examination which requires holding the child on their back and which is potentially time-consuming.
- Trial name
- CAPNIRS (NCT06153771)
- Testing
- Collection of brain and kidney NIRS measurements, echocardiography
- Where
- France
- Volunteers
- 26 people, healthy volunteers welcome
- Sponsor
- Centre Hospitalier Universitaire Dijon
Endothelial Dysfunction, Sublingual Capillary Glycocalyx and Density
Prematurity as Predictor of Children's Cardiovascular-renal Health
Extreme preterm birth interferes with the development of the cardiovascular system. Both macro- as well as microvasculature undergoes extensive, organ specific maturation.
- Conditions
- Endothelial Dysfunction, Sublingual Capillary Glycocalyx and Density, Visual Disturbances and Blindness, Ventricular Dysfunction, Left
- Trial name
- PREMATCH (NCT02147457)
- Where
- Belgium
- Volunteers
- 180 people, healthy volunteers welcome
- Sponsor
- Universitaire Ziekenhuizen KU Leuven
Preterm Birth, Inadequate Milk Production
Milk Volume Outcomes Following Oral Nicotinamide Riboside Supplementation in Mothers of Extremely Preterm Infants
This study aims to evaluate the feasibility and effects of nicotinamide riboside (NR) supplementation in lactating mothers of infants expected to be hospitalized in the neonatal intensive care unit (NICU) for at least four weeks.
- Trial name
- MOONRISE (NCT04614714)
- Testing
- Nicotinamide Riboside (NR)
- Where
- United States
- Volunteers
- 40 people, healthy volunteers welcome
- Sponsor
- University of California, Davis
Respiratory Distress Syndrome, Preterm Birth
LISA vs INSURE in Extremely Low Birth Weight Infants. A Manikin Study
This is an unblinded, randomized, controlled, crossover (AB/BA) trial of surfactant treatment with LISA vs. INSURE in a manikin simulating an extremely low birth weight infant.
- Conditions
- Respiratory Distress Syndrome, Preterm Birth, Surfactant Deficiency Syndrome Neonatal
- Trial name
- NCT04944108
- Testing
- LISA approach, Insure approach
- Where
- 2 sites in Italy
- Volunteers
- 42 people, healthy volunteers welcome
- Sponsor
- University Hospital Padova
Infant, Extremely Premature, Voice
Maternal Voice on Alleviating Pain in Premature Undergoing Heel Lance Procedure and Enhancing Mother-Infant Bonding
A total of 64 preterm infants born before 37 weeks of gestation and their mothers were randomly assigned to the experimental and control groups.
- Conditions
- Infant, Extremely Premature, Voice, Pain, Bonding
- Trial name
- NCT04158206
- Testing
- Maternal voice
- Where
- Taiwan
- Volunteers
- 64 people, healthy volunteers welcome
- Sponsor
- National Yang Ming Chiao Tung University
Infant, Newborn, Infant, Low Birth Weight
Development of Standards for the New Ballard Maturation Score
The primary purpose of this study was to evaluate the accuracy of gestational age (GA) estimates by using the New Ballard Score (NBS) in newborns 24 to 27 weeks GA with accurate obstetric estimates of GA.
- Conditions
- Infant, Newborn, Infant, Low Birth Weight, Infant, Small for Gestational Age, Infant, Premature
- Trial name
- Ballard (NCT01203449)
- Where
- 11 sites in United States
- Volunteers
- 1,090 people, healthy volunteers welcome
- Sponsor
- NICHD Neonatal Research Network
Infection, Candida
Early Diagnosis of Candidiasis in Premature Infants
This observational study evaluated the performance of new lab tests in detecting candida species fungal infections in extremely low birth weight (ELBW) infants quickly and accurately.
- Conditions
- Infection, Candida, Candidiasis, Infant, Newborn
- Trial name
- Candida (NCT00109525)
- Where
- 20 sites in United States
- Volunteers
- 1,500 people, healthy volunteers welcome
- 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
Respiratory Distress Syndrome, Newborn
LISA Catheter With Marked vs. Unmarked Tip in Extremely Low Birth Weight Infants With RDS
This is an unblinded, randomized, controlled, crossover (AB/BA) trial of surfactant treatment with LISA catheter with a marked tip vs.
- Trial name
- NCT05399628
- Testing
- Surfactant administration with less invasive surfactant administration (LISA) marked tip catheter, Surfactant administration with less invasive surfactant administration (LISA) unmarked tip catheter
- Where
- Italy
- Volunteers
- 50 people, healthy volunteers welcome
- Sponsor
- University Hospital Padova
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
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
Hemodynamically Significant Patent Ductus Arteriosus
Research on the Individualized Treatment Strategy for Extremely Preterm Infants With hsPDA Based on Biomarkers and Targeted Delivery Systems
This project aims to address the need for individualized precision therapy for hemodynamically significant patent ductus arteriosus (hsPDA) in extremely preterm infants by integrating clinical biomarker screening with the design…
- Trial name
- BTDS-IT-hsPDA- (NCT07374146)
- Volunteers
- 80 people, healthy volunteers welcome
- Sponsor
- Peking University Third Hospital
Infant, Extremely Premature
Milking the Umbilical Cord for Extreme Preterm Infants
Milking the umbilical cord from the placental end toward the infant has been shown to benefit preterm infants when compared to either clamping the umbilical cord immediately or waiting delaying the clamping of the cord.
- Trial name
- NCT01666847
- Testing
- Milking the umbilical cord before cord clamping
- Where
- 2 sites in United States
- Volunteers
- 59 people, healthy volunteers welcome
- Sponsor
- St. Louis University