Prematurity Clinical Trial
Official title:
Randomized Indomethacin Germinal Matrix Hemorrhage/Intraventricular Hemorrhage (GMH/IVH) Prevention Trial
The purpose of this multicenter trial is to determine if indomethacin prevents bleeding in the brain of very low birth weight preterm infants.
Intraventricular hemorrhage (IVH) or bleeding in the brain remains a major problem of
preterm infants. This randomized, placebo-controlled multicenter trial enrolled 505 infants
of 600 to 1250g birth weight to determine if indomethacin lowers the incidence of IVH, and
125 term infant controls. During this longitudinal trial, follow-up assessments have been
performed at the ages of 3, 4 1/2, 6, 8, 12 and 16 years. The initial results at age 3 years
revealed no advantages to the indomethacin group over and above the decreases in IVH,
however, the results did show a significant increase in ventriculomegaly in the "placebo"
group. Results at 4 1/2, 6 and 8 years of age showed beneficial effects of indomethacin on
cognitive and behavioral outcomes over and above the effects on preventing IVH but not at
later ages. At 12 and 16 years, no significant influence of indomethacin on cognitive
outcome was noted.
Age, gender and zip-code matched control subjects were added when the preterm subjects were
8 years. Throughout all subsequent testing, term controls have higher IQ and Peabody Picture
Vocabulary Scores.
Additional longitudinal volumetric, functional and diffusion tensor MR imaging studies
showed differences between preterm and term control subjects at 8, 12 and 16 years of age.
These were consistent with utilization of the right hemisphere and left cerebellum for
language in the preterm group compared to term controls. No effects of indomethacin were
seen.
The study closed on 31 March 2012.
;
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Prevention
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Recruiting |
NCT03670732 -
CPAP vs.Unsynchronized NIPPV at Equal Mean Airway Pressure
|
N/A | |
| Completed |
NCT05322161 -
Yoga in the NICU for Parents Study
|
N/A | |
| Recruiting |
NCT04542096 -
Real Time Evaluation of Dynamic Changes of the Lungs During Respiratory Support of VLBW Neonates Using EIT
|
||
| Recruiting |
NCT04911452 -
Creating a Calmer NICU: Optimizing Growth and Brain Development in Preterm Infants
|
N/A | |
| Recruiting |
NCT02901652 -
NIPPV and nBiPAP Methods in Preterm Infants With Respiratory Distress Syndrome
|
N/A | |
| Completed |
NCT02148965 -
Effects of Exercise During Pregnancy on Maternal and Child Health: a Randomized Clinical Trial
|
N/A | |
| Completed |
NCT02273843 -
A Trial on Different Dosages of Vitamin D in Preterm Infants With Late-onset Sepsis
|
Phase 1 | |
| Terminated |
NCT02032511 -
Comparison of RAM Cannula Nasal Continuous Positive Airway Pressure Versus Infant Flow Nasal Continuous Positive Airway Pressure (NCPAP)
|
N/A | |
| Completed |
NCT01721629 -
Weaning of Nasal Continuous Positive Airway Pressure (CPAP) in Premature Infants
|
N/A | |
| Terminated |
NCT01819532 -
Milking the Umbilical Cord Versus Immediate Clamping in Pre-term Infants < 33 Weeks
|
N/A | |
| Completed |
NCT00951860 -
Assessment of Autonomic Maturation in Neonatal Period and Early Neural Development From a Longitudinal Prospective Cohort
|
N/A | |
| Completed |
NCT01523769 -
Umbilical Cord Milking on the Reduction of Red Blood Cell Transfusion Rates in Infants
|
N/A | |
| Completed |
NCT01478711 -
Comprehensive Clinical Decision Support (CDS) for the Primary Care of Premature Infants
|
N/A | |
| Completed |
NCT00749008 -
Study of Generalized Movements for Early Prediction of Cerebral Palsy
|
N/A | |
| Completed |
NCT00787124 -
Transfusions and Nitric Oxide Level in Preterm Infants
|
||
| Terminated |
NCT01208493 -
Dietary Protein in the Very-low-birth-weight Infant
|
N/A | |
| Terminated |
NCT00486395 -
Will CPAP Reduce Length Of Respiratory Support In Premature Infants?
|
Phase 3 | |
| Completed |
NCT00527956 -
Facilitation and Barriers to Breastfeeding in the NICU
|
N/A | |
| Completed |
NCT03372590 -
NEO Rehab for Infants at Risk of Cerebral Palsy
|
N/A | |
| Completed |
NCT05508308 -
Automated Versus Manual Control Of Oxygen For Preterm Infants On Continuous Positive Airway Pressure In Nigeria
|
N/A |