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Infant, Premature clinical trials

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NCT ID: NCT00579553 Completed - Premature Birth Clinical Trials

Comparing IM vs. Vaginal Progesterone for Pre-term Birth

Start date: October 2006
Phase: N/A
Study type: Interventional

This is a randomized controlled trial comparing weekly intramuscular injection of 17 alpha hydroxylprogesterone caproate with daily vaginal progesterone in women with singleton pregnancies and history of prior spontaneous preterm birth in terms of maternal, fetal and neonatal outcomes. Our aim is to assess the effects on maternal, fetal and neonatal outcomes of antenatal progesterone administered intramuscularly versus vaginally in women with singleton pregnancy and a history of prior preterm birth.

NCT ID: NCT00552383 Completed - Infant, Premature Clinical Trials

The Edmonton Randomised Controlled Trial of NIDCAP - Based Developmental Care

NIDCAP
Start date: September 1998
Phase: N/A
Study type: Interventional

NIDCAP based developmental care is a method of looking after preterm infants that is guided by the infant's behavioural cues, and that actively involves parents in the care of their infant. There is limited evidence that outcomes for infants are improved if they receive NIDCAP based care. This study evaluates the effects of introducing NIDCAP based care to a level III neonatal intensive care unit, in the post - surfactant era, and also evaluates its effects on developmental outcomes at age 18 months.

NCT ID: NCT00536445 Withdrawn - Infant, Premature Clinical Trials

Use of NAVA in Intubated Preterm

Start date: October 2007
Phase: Phase 1/Phase 2
Study type: Interventional

The present protocol will demonstrate the feasibility and efficacy of a newly developed mode of mechanical ventilation, Neurally Adjusted Ventilatory Assist, commonly known as NAVA. During NAVA, the timing and magnitude of pressure delivered are controlled by the infants' diaphragm electrical activity (EAdi), a validated measurement of neural respiratory drive. Recent clinical trials in adults and term infants have shown that NAVA is more synchronous than conventional pressure support ventilation, and that NAVA delivers lower mean airway pressures to achieve the same ventilation and respiratory muscle unloading. NAVA has recently been approved for use in neonates by Health Canada and the FDA in the United States, and is commercially available on the Servoi ventilator (Maquet Critical Care, Solna, Sweden). The present protocol is designed as a "case study" where the researchers responsible would like to evaluate the feasibility and efficacy of ventilating a premature baby on NAVA with the Servoi for 12 hours.

NCT ID: NCT00528736 Completed - Infant, Premature Clinical Trials

Plasma B-Type Natriuretic Peptide Concentrations in Preterm Infants < 28 Weeks

Start date: August 2005
Phase: N/A
Study type: Observational

The aim of the study was to evaluate BNP in preterm infants < 28 weeks on the second day of life, when it is still unknown, if a patent ductus arteriosus is hemodynamic significant or not. We hypothesized that high plasma BNP concentrations on day 2 are associated with the need of PDA intervention in the further course.

NCT ID: NCT00455169 Completed - Influenza Clinical Trials

Influenza Vaccine in Premature Infants

Start date: October 2007
Phase: Phase 4
Study type: Observational

Background. Influenza is increasingly recognized as causing severe respiratory illness in children. High-risk infants, like former premature infants, and particularly those with lung disease, have influenza hospitalization rates about five times higher than healthy children. Influenza vaccine does not protect young children against influenza as well as it does healthy adults. A small study that measured antibodies (proteins that protect against infection) to influenza suggested that premature infants get even less protection from influenza vaccine than full-term infants. More information about influenza vaccine in premature infants is needed. The overall goals of this project are to collect information about the how well the influenza vaccine induces antibody production, and to develop the collaborative network of centers necessary for a larger trial of influenza vaccine in premature infants. Objective and Hypotheses. The objective of this study is to measure the amount of protective antibody produced by influenza vaccine in premature (less than 30 weeks' [about 7 months] gestation at birth), extremely-low-birth-weight (1000 grams [2¼ pounds] or less at birth) infants. Influenza vaccine needs to be given yearly. We will assess premature infants during their first series of influenza vaccines. We hypothesize that the levels of antibody will be lower in premature infants receiving their first series of influenza vaccine than in full-term infants. Design. We will measure the immune response in premature and full term infants. During the 2007-2008 influenza season, a total of 92 subjects, divided among 2 groups (premature infants 6-17 months old receiving their first influenza vaccine series and full-term infants 6-17 months old receiving their first influenza vaccine series) will be recruited at a consortium of five centers (the University of Rochester, the University of Texas Southwestern Medical Center, Wake Forest University, the University of Miami and the State University of New York at Buffalo), receive 2 doses of influenza vaccine, and have antibody and immune cell responses to each vaccine component measured 4-6 weeks after the second dose of vaccine. Potential Impact. If this study and future investigations suggested ways to improve premature infants influenza vaccine responses, they could lead to changes in recommendations for the number or timing of vaccine doses or of the type of vaccine used in this high-risk group.

NCT ID: NCT00428038 Completed - Asthma Clinical Trials

Assessment of the Pulmonary Diffusion Capacity in Healthy Infants and Infants With Chronic Lung Disease

Start date: February 2004
Phase: N/A
Study type: Observational

The purpose of this study is to evaluate how easily gas can be taken up by the lung. We are comparing infants born premature <32 weeks gestation to infants born full term >37 weeks. We hope to evaluate the differences between the two groups in order to learn more about premature lung growth and development.

NCT ID: NCT00369005 Completed - Anemia Clinical Trials

Liberal Versus Restrictive Transfusion Guidelines for Preterm Infants

Start date: December 1992
Phase: N/A
Study type: Interventional

The purpose of this study was to determine whether restrictive guidelines for red blood cell (RBC) transfusions for preterm infants can reduce the number of transfusions without adverse consequences.

NCT ID: NCT00368485 Completed - Infant, Premature Clinical Trials

Neural Control of Non-invasive Ventilation in the Preterm

Start date: August 2006
Phase: Phase 1
Study type: Interventional

The present study will use a new type of respirator in premature babies who need help with their breathing. This new respirator uses signals from the baby's diaphragm - the most important breathing muscle - to control the timing and the amount of air that the baby needs. The goal of the study is to demonstrate that this new respirator can synchronize delivery of air to the baby's efforts, and that synchrony is maintained regardless of whether the baby is breathing with a tube or a mask.

NCT ID: NCT00365703 Completed - Infant, Premature Clinical Trials

Nasogastric Tube vs. Orogastric Feeding Tube in Preterm Infants: Which is Best?

Start date: September 2006
Phase: N/A
Study type: Interventional

The purpose of this study is to find out which method (nasogastric vs. orogastric) of feeding tube for premature infants results in earlier only oral feeding.

NCT ID: NCT00349726 Completed - Clinical trials for Retinopathy of Prematurity

Single-Dose Intravenous Inositol Pharmacokinetics in Preterm Infants

INS-1
Start date: June 2006
Phase: Phase 2
Study type: Interventional

This pilot study was 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 a single intravenous dose 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 was to evaluate the single-dose pharmacokinetics and safety of different amounts of intravenous myo-inositol (provided by Ross Products Division, Abbott Laboratories) in very low birth weight neonates, in preparation for a future Phase III multi-center randomized controlled trial. This study enrolled 74 infants at high risk for retinopathy at 9 NICHD Neonatal Research Network sites, and randomly assigned them to receive either 60mg/kg of 5% inositol, 120 mg/kg of 5% inositol, 60 mg/kg of 5% glucose (the placebo), or 120 mg/kg of 5% glucose.