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Infant, Premature clinical trials

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NCT ID: NCT01203488 Completed - Sepsis Clinical Trials

Vitamin A Supplementation for Extremely-Low-Birth-Weight Infants

Vitamin A
Start date: January 1996
Phase: Phase 1/Phase 2
Study type: Interventional

This multi-site, randomized trial was conducted to determine the safety and effectiveness of a higher dose of vitamin A and determine if this would increase the rate of survival without bronchopulmonary dysplasia (BPD) and reduce the risk of sepsis. Infants with birth weights from 401-1000g and who were on mechanical ventilation or supplemental oxygen at 24-96 hours of age were enrolled. Subjects were randomized to either the Vitamin A or a control group. Infants in the Vitamin A group were given a dose of 5000 IU (0.1 ml) intramuscularly on Mondays, Wednesdays, and Fridays for four weeks. Control infants received a sham procedure rather than placebo injections.

NCT ID: NCT01203475 Completed - Infant, Premature Clinical Trials

Growth Observational Study

Growth
Start date: August 1994
Phase: N/A
Study type: Observational

This study was a multicenter, prospective cohort study to define postnatal longitudinal growth for very low birth weight (VLBW) infants. The objectives were: 1) to develop postnatal growth curves for VLBW preterm infants that would permit an assessment of growth velocity; 2) to relate growth velocity and nutritional practices (duration of parenteral nutrition, age at first enteral feeding, and age at full enteral feeding); 3) to compare growth velocity in infants who are small-for-gestational age (SGA) with infants who are appropriate-for-gestational age (AGA); and 4) to relate growth velocity to several common, major morbidities, including chronic lung disease (CLD), nosocomial infection (or late-onset infection) and necrotizing enterocolitis (NEC). These growth data may be useful in identifying preterm infants who are growing slowly despite current nutritional support and in designing and performing clinical trials of nutritional interventions.

NCT ID: NCT01203449 Completed - Pregnancy Clinical Trials

Development of Standards for the New Ballard Maturation Score

Ballard
Start date: June 1994
Phase: N/A
Study type: Observational

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. Secondary purposes were: (1) to compare the accuracy of GA estimates derived from the NBS, the original Ballard score, and the physical items of the original Ballard score and (2) to compare these measures of GA and best obstetric estimates of GA as predictors of survival, morbidity, and hospital stay among infants <28 weeks' gestation and among very low birth weight infants in general.

NCT ID: NCT01203436 Completed - Clinical trials for Retinopathy of Prematurity

Supplemental Therapeutic Oxygen for Prethreshold Retinopathy of Prematurity

STOP-ROP
Start date: February 1994
Phase: Phase 2/Phase 3
Study type: Interventional

The purpose of this trial was to determine the efficacy and safety of supplemental therapeutic oxygen for infants with prethreshold retinopathy of prematurity (ROP) to reduce the probability of progression to threshold ROP and the need for peripheral retinal ablation.

NCT ID: NCT01203423 Completed - Infant, Premature Clinical Trials

Persistent Pulmonary Hypertension of the Newborn (PPHN) Observational Study

PPHN
Start date: October 1993
Phase:
Study type: Observational

This study was an observational study to estimate the prevalence of Persistent pulmonary hypertension of the newborn (PPHN) among term or near-term infants with severe respiratory disease.

NCT ID: NCT01203358 Completed - Clinical trials for Bronchopulmonary Dysplasia

Exosurf Neonatal and Survanta for Treatment of Respiratory Distress Syndrome

Surfactant 1
Start date: January 1991
Phase: Phase 2/Phase 3
Study type: Interventional

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.

NCT ID: NCT01203345 Completed - Sepsis Clinical Trials

Intravenous Immune Globulin (IVIG) to Prevent Neonatal Infection

IVIG
Start date: January 1988
Phase: Phase 2/Phase 3
Study type: Interventional

A controlled clinical trial was conducted at eight participating centers between January 1, 1988, and March 31, 1991. Patients were randomly assigned to an intravenous immune globulin group or a control group. There were two phases to the study (see below). During phase 1 the control infants received infusions of placebo. During phase 2 the control infants received no infusion therapy.

NCT ID: NCT01193270 Completed - Infant, Premature Clinical Trials

Vitamin E for Extremely Preterm Infants

Start date: October 2010
Phase: Phase 1
Study type: Interventional

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 weight). This pilot will examine whether a single dose of vitamin E will be absorbed into the infants' bloodstreams with resulting serum α-tocopherol level in the target range of 1-3 mg/dl.

NCT ID: NCT01056653 Completed - Infant, Premature Clinical Trials

Fathers and Late Preterm Babies Study

FLPTB
Start date: March 2009
Phase: N/A
Study type: Interventional

The purpose of this study is to test an educational intervention for first-time fathers of late preterm (34 to 36 weeks gestation) infants.

NCT ID: NCT01035697 Completed - Cerebral Palsy Clinical Trials

Inflammatory Cytokines Associated With Perinatal Brain Injury

Cytokines
Start date: July 1999
Phase:
Study type: Observational

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 18-22 months corrected age.