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Premature Birth clinical trials

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NCT ID: NCT00903149 Completed - Premature Births Clinical Trials

Long-term Effect of The Mother Infant Transaction Program (MITP)

2007/2/0150
Start date: January 2007
Phase: N/A
Study type: Observational

The purpose of this study is to investigate if a cost and time effective intervention in a previous RCT for preterm infants and their parents can reduce the parents experience of concern and stress, and improve the childrens development in various aspects at three years of corrected age. Hypothesis 1: The preterm born children of parents who were enrolled in the earlier RCT have a higher developmental level then preterm children of parents who received the usual treatment. Hypothesis 2: Parents who who were enrolled in the earlier RCT will have a lower level of stress and concern then parents who received treatment as usual.

NCT ID: NCT00895869 Completed - Pain Clinical Trials

Pain in Neonates During Screening for Retinopathy of Prematurity Using Two Methods

RETCAM
Start date: April 2004
Phase: N/A
Study type: Observational

Retinopathy of prematurity screening is painful. Wide field digital retinal imaging (WFDRI) and binocular indirect ophthalmoscopy (BIO) are being used for screening examinations. The aim of Edinburgh, UK based study is to compare the pain experienced by infants using both examination techniques.

NCT ID: NCT00892476 Completed - Myopia Clinical Trials

Prevention of Myopia of Prematurity by Calcium Supplementation

Start date: February 2002
Phase: Phase 1
Study type: Interventional

The purpose of this study is to determine if supplementation of calcium by the enteral route (gut feeding) to extremely low birth weight infants will lead to less myopia (nearsightedness) at 6-12 months postnatal age. Secondly, the study will determine if calcium supplementation is well tolerated, if it reduces the molding of these premature infants' heads, and if it decreases myopia at the 18-22 month postnatal age visit.

NCT ID: NCT00883974 Completed - Preterm Birth Clinical Trials

Sensitivity Training For Parents of Preterm Infants

Start date: April 2004
Phase: N/A
Study type: Interventional

Immediately following birth, preterm infants face a period of stressful environmental inputs, which may have negative consequences on early brain development and subsequent neurobehavioral outcomes. This study aimed to assess the effectiveness of training parents in reducing stressful experiences early in life. The investigators hypothesized that this intervention would insulate preterm infants from the harmful effects of acute and chronic stress, which in turn would result in enhanced brain development. The primary aim of the current study was to investigate if this intervention was associated with improved brain development measured by magnetic resonance imaging (MRI) at term-equivalent age. A secondary aim was to assess some possible short-term medical benefits.

NCT ID: NCT00883324 Completed - Preterm Delivery Clinical Trials

Comparison of Fetal Fibronectin (fFN) Specimen Collection Methodologies: With Speculum Versus Without Speculum

SpecOp
Start date: March 2009
Phase: N/A
Study type: Observational

Observational study to determine whether the proposed method of fFN specimen collection without a speculum is substantially equivalent to the approved method with a speculum examination when obtained at the gestational age of ≥ 24 weeks and ≤ 34, 6 days in symptomatic women and at the gestational age of ≥ 22 weeks, 0 days and ≤ 30, 6 days in asymptomatic women. A finding of substantial equivalency would support a modification to the labeling to allow the collection of specimens for fFN determination with or without a speculum examination.

NCT ID: NCT00874393 Completed - Blood Pressure Clinical Trials

Early Blood Pressure Management in Extremely Premature Infants

ELGAN BP
Start date: July 2009
Phase: Phase 1
Study type: Interventional

This trial tests the feasibility of enrolling 60 extremely preterm infants in a randomized, double-blinded study of blood pressure management within 12 months. Eligible infants will receive an infusion drug (dopamine or a dextrose placebo) and a syringe drug (hydrocortisone or a normal saline placebo). Enrolled infants will be randomized to receive one of the following drug pairs: - dopamine and hydrocortisone - dopamine and normal saline - dextrose and hydrocortisone - dextrose and normal saline. In addition to the intervention above, the NRN is conducting a 6-month time-limited prospective observational study of all infants born at an NRN center between 23 and 26 weeks gestational age. All clinical decisions made for these babies will be at the discretion of the attending neonatologist/infant care team according to standard practice at each institution. Data on blood pressure management in the first 24 postnatal hours collected for each infant.

NCT ID: NCT00873847 Completed - Infant, Premature Clinical Trials

Cerebral Function Monitoring in Premature Infants

Start date: July 2009
Phase: N/A
Study type: Observational

This observational study tests the feasibility of enrolling subjects and obtaining an amplitude-integrated electroencephalogram (aEEG) within the first 72 hours of life, a second aEEG recording between 72-168 hours of life, and weekly thereafter up to 36 weeks post-menstrual age. It will enroll 85-100 infants between 401-1,000 grams birth weight OR between 23 0/7 and 28 6/7 weeks gestational age born at the 7 participating NICHD Neonatal Research Network sites.

NCT ID: NCT00866567 Completed - Prematurity Clinical Trials

Defects in Opsonophagocytosis in Premature Infants

Start date: October 2008
Phase: N/A
Study type: Observational

The purpose of the study is to characterize innate immune function of premature infants, and identify defects that may be responsible for the development of bacterial sepsis.

NCT ID: NCT00865150 Completed - Prematurity Clinical Trials

Amino Acid and Acylcarnitine Profiles in Premature Neonates

Start date: April 2009
Phase: N/A
Study type: Observational

Primary Hypotheses of the study include: - Metabolic profiles are influenced by gestational age, chronological age, type and degree of nutritional support and illness - Metabolic profiles differ between neonates who receive commercial formula and neonates who receive primarily human breast milk - Neonates who develop parenteral associated cholestasis have metabolic markers that identify at risk patients (high serum urea nitrogen, citrulline, histidine, methionine, and succinyl carnitine and low thyroxine, serine and glutamate) - Neonates that have hypothyroidism have abnormal metabolic profiles (low tyrosine levels)

NCT ID: NCT00861484 Completed - Clinical trials for Premature Ejaculation

Proof of Mechanism in ELT

PoM
Start date: November 26, 2008
Phase: Phase 1
Study type: Interventional

The purpose of this study is to determine if the administration of GSK958108 can delay ejaculation in patients with primary premature ejaculation as measured by the ejaculatory latency time (ELT) using the masturbation model and sexual visual stimulation, and to evaluate the safety and tolerability of GSK958108 in healthy men with PE