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Infant, Low Birth Weight clinical trials

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NCT ID: NCT00197548 Completed - Pregnancy Clinical Trials

A Trial of Micronutrients and Adverse Pregnancy Outcomes

Start date: August 2001
Phase: Phase 3
Study type: Interventional

The purpose of this study is to examine the efficacy of multivitamin supplementation on fetal loss, low birth weight and severe preterm birth in healthy (HIV negative) women.

NCT ID: NCT00114543 Completed - Infant, Premature Clinical Trials

Trial of Aggressive Versus Conservative Phototherapy in Infants <1,000 Grams Birth Weight

Phototherapy
Start date: September 2002
Phase: Phase 3
Study type: Interventional

This multi-center, randomized clinical trial compared different bilirubin levels as thresholds for timing of phototherapy in extremely low birth weight infants. The primary hypothesis was that there would be no difference in death or neurodevelopmental impairment at 18-22 months corrected age in infants treated by either aggressive or conservative threshold limits. 1,978 infants were enrolled.

NCT ID: NCT00109525 Completed - Infection Clinical Trials

Early Diagnosis of Candidiasis in Premature Infants

Candida
Start date: March 2004
Phase:
Study type: Observational

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. 19 NICHD Neonatal Research Network sites enrolled 1,500 infants with birth weights ≤1,000g; 100 of these infants later tested positive for candidiasis. Blood, urine, and lumbar puncture samples were collected whenever other specimens were obtained from participants for cultures. These samples are being tested using the new methods and compared with standard culture results. Surviving study subjects completed a neurodevelopmental evaluation at 18-22 months corrected age.

NCT ID: NCT00067613 Completed - Infant, Premature Clinical Trials

Benchmarking Initiative to Reduce Bronchopulmonary Dysplasia

Benchmarking
Start date: March 2001
Phase: N/A
Study type: Interventional

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 improvement would change practices and improve rates of survival without BPD in inborn neonates with birth weights of <1250 grams. Benchmarking is a method involving detailed comparisons of processes between similar organizations. For this study, three NRN centers with the lowest rates of BPD have been identified as Benchmark centers. During a 6-month pre-intervention period, details of care practices and management style at these centers were carefully assessed. Based on practices at these Benchmarking sites, we developed a quality improvement program. For this study, 14 other NRN sites were randomized to either implement the benchmarking intervention (intervention sites) or continue with their usual care practices (control sites). After the 1-year intervention period, we compared changes in the rate of survival without BPD at 36 weeks corrected age between the intervention and control sites.

NCT ID: NCT00063063 Recruiting - Infant, Premature Clinical Trials

Generic Database of Very Low Birth Weight Infants

GDB
Start date: January 1987
Phase:
Study type: Observational

The Generic Database (GDB) is a registry of very low birth weight infants born alive in NICHD Neonatal Research Network (NRN) centers. The GDB collects observational baseline data on both mothers and infants, and the therapies used and outcomes of the infants. The information collected is not specific to a disease or treatment (i.e., it is "generic"). Data are analyzed to find associations and trends between baseline information, treatments, and infant outcome, and to develop future NRN trials.

NCT ID: NCT00016523 Terminated - Sepsis Clinical Trials

Inhaled Nitric Oxide for Preterm Infants With Severe Respiratory Failure

Preemie iNO
Start date: January 2001
Phase: Phase 3
Study type: Interventional

This multicenter trial tested whether inhaled nitric oxide would reduce death or the need for oxygen in preterm infants (less than 34 weeks gestational age) with severe lung disease.

NCT ID: NCT00015613 Completed - Clinical trials for Infant, Premature, Diseases

Farm Work & Preterm Low Birthweight Among Hispanic Women

Start date: August 1998
Phase: N/A
Study type: Observational

The most persistent and intractable cause of infant and child mortality and morbidity in the US remains preterm and low birthweight deliveries. Pregnant women in the United States experience the highest incidence of these complications among developed countries. Even more disturbing is the observation that immigrant Hispanic women experience worsening birth outcomes the longer they live here, despite increasing access to prenatal care, improved socio-economic status and better education. The purpose of this study is to identify the potential acculturation-related risk factors for preterm and low birthweight (PTLBW) delivery among Hispanic women of varying lengths of US residency. It is hypothesized that changes in factors associated with acculturation, such as poor nutritional intake, job stress and occupational exposures to pesticides or other hazards, and certain types of genital infections, can best explain the worsening of pregnancy outcomes among Hispanic immigrant women.

NCT ID: NCT00011362 Completed - Clinical trials for Bronchopulmonary Dysplasia

Dexamethasone Therapy in VLBW Infants at Risk of CLD

Dexamethasone
Start date: September 1992
Phase: Phase 3
Study type: Interventional

Infants who are on breathing support are often treated with steroids (dexamethasone); however, the best timing of therapy is not known. This trial looked at the benefits and hazards of starting dexamethasone therapy at two weeks of age and four weeks of age in premature infants.

NCT ID: NCT00009633 Recruiting - Infant, Premature Clinical Trials

Follow-up Visit of High Risk Infants

FU
Start date: January 1993
Phase:
Study type: Observational

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 assessments at 22-26 months corrected age (Infants born prior to July 1, 2012 were seen at 18-22 months corrected age). Data regarding pregnancy and neonatal outcome are collected prospectively. The goal is to identify potential maternal and neonatal risk factors that may affect infant neurodevelopment.

NCT ID: NCT00009620 Completed - Infant, Premature Clinical Trials

Antenatal Phenobarbital to Prevent Neonatal Intracranial Hemorrhage

Phenobarbital
Start date: February 1993
Phase: Phase 3
Study type: Interventional

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. Women with 24 to 32 week fetuses who were in preterm labor and were expected to deliver within 24 hrs were randomized to phenobarbital or usual care. They were treated until they deliver or the fetus reaches 33 wks gestation. Babies were followed until discharge and evaluated at 18-22 mos corrected age for neurodevelopmental outcome.