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Infant, Newborn clinical trials

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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: NCT01203410 Completed - Infant, Newborn Clinical Trials

Prediction of Jaundice in Term Infants

Start date: November 1991
Phase:
Study type: Observational

The objective of this study was to describe total bilirubin production in healthy term infants as a means of understanding the differences in jaundice pigment production associated with various common clinical circumstances.

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: NCT01086878 Completed - HIV Infections Clinical Trials

Safety of Cotrimoxazole in HIV- and HAART-exposed Infants

Start date: February 2009
Phase: Phase 4
Study type: Interventional

The purpose of this study is to determine if prophylactic cotrimoxazole makes severe anemia or neutropenia more common in infants exposed to maternal HIV and combination antiretroviral therapy.

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.

NCT ID: NCT01030575 Completed - Clinical trials for Retinopathy of Prematurity

Multi-dose Pharmacokinetics and Dose Ranging of Inositol in Premature Infants (INS-2)

INS-2
Start date: January 2010
Phase: Phase 2
Study type: Interventional

This pilot study is a randomized, placebo-controlled, clinical trial to measure changes in blood and urine levels of inositol in premature infants at high risk for retinopathy of prematurity (ROP) following repeated doses of inositol. Based on previous studies, the premise is that maintaining inositol concentrations similar to those occurring naturally in utero will reduce the rates of ROP and bronchopulmonary dysplasia in premature infants. The objective is to evaluate pharmacokinetics, safety, and clinical outcomes of multiple doses of three different dose amounts of myo-inositol (provided by Abbott Laboratories) in very low birth weight premature infants. This study will enroll an estimated 96 infants at 17 NICHD Neonatal Research Network sites. Infants will be randomly assigned to receive either 10 mg/kg of 5% inositol, 40 mg/kg of 5% inositol, 80 mg/kg of 5% inositol, or 5% glucose given in the same volumes and timings as the inositol dosage to maintain masking. Enrollees will receive their assigned dose or placebo daily, starting within 72 hours of birth, and continuing until they reach 34 weeks post-menstrual age, 10 weeks chronologic age, or until the time of hospital discharge, whichever occurs first. The study drug will be administered first intravenously; as the infants progress to full feeding, the drug will be given enterally (orally or via feeding tube). Enrollees will be seen for a follow-up examination at 18-22 months corrected age. This pilot study is in preparation for a future Phase III multi-center randomized controlled trial.