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Birth Weight clinical trials

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NCT ID: NCT01164124 Completed - Low Birth Weight Clinical Trials

Probiotics-Supplemented Feeding in Extremely Low Birth Weight Infants

PAS
Start date: February 2008
Phase: Phase 2/Phase 3
Study type: Interventional

The overall purpose of this research is to test whether adding a supplement to the feeding of extremely low birth weight infant (infants weighing less than 2 pound 2 oz at birth) will help him/her achieve full feeding faster and achieve better weight gain.

NCT ID: NCT01163188 Completed - Premature Birth Clinical Trials

Social Adjustment and Quality of Life After Very Preterm Birth

Start date: September 2010
Phase: N/A
Study type: Observational

The major aim is the follow-up of the highest risk group (< 32 weeks gestation/ < 1500 birthweight) and their controls of the Bavarian Longitudinal Study (BLS) at the age of 24-27 years. The focus will be the identification of risk, protective and resiliency factors for cognitive and behavioural development and quality of life. MRIs of the central nervous system will be conducted to examine aberrant activation patterns during the "attention network task" in stratified subgroups. Data driven MRI methods will be evaluated in relation to clinical, behavioural and developmental parameters.

NCT ID: NCT01150071 Completed - Clinical trials for Lung Diseases, Obstructive

Growth, Health and Development in Children Born Extremely Preterm

PEP11
Start date: August 2010
Phase: N/A
Study type: Observational

Background: In a national Norwegian cohort of children born before 28 weeks gestation or with a birth weight less than 1000 g born in 1999 and 2000, 372 survived. Compared with earlier studies survival increased for the most immature infants, but at the cost of more early complications and a high rate of impairments, while the less immature children had fewer early complications and less impairments detectable within 5 years. These changes show the importance of monitoring outcome as treatment modalities change. Large brain haemorrhages were highly predictive of severe disabilities, but we have not found good predictive factors for milder impairments such as cognitive, behavioural and motor difficulties. However, at 5 years later function may be difficult to predict, and the children's potentials are better understood after completing several years in school. Objectives: The children will be re-examined at age 11 in order to assess their physical and mental health, and cognitive, motor and social function, and to determine if early life events and development at 2 and 5 years are predictive of long term health and functioning. MRI-studies, including functional MRI will be performed to examine if different outcomes related to brain function can be explained by differences in brain development. Methods: For all, data will be collected from the compulsory national test in 5th grade and questionnaires to the child, parents and teacher. For children in Western Norway (n=87) extensive examinations of lung and brain function, including clinical diagnostic tests and MRI, will be added. For all aspects of the study the investigators have appropriate current and historic reference populations for comparison. Implications: Knowledge on causes and of early predictions of outcome is needed to give appropriate advice to families, professionals and society, and to develop preventive programs.

NCT ID: NCT01136681 Completed - Premature Birth Clinical Trials

Wales Electronic Cohort for Children

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

The investigators are developing a research platform capable of improving children's health through the generation of knowledge from analysis of routinely collected data from within and outside the health service. The investigators are using the data that are routinely collected in Wales to answer specific questions about child health and well-being, with the aim of informing policy and practice in Wales, whilst also being internationally relevant. Routinely collected datasets are publicly funded, and have already been incorporated into the Secure Anonymised Information Linkage databank. The investigators are combining these datasets on children from health and social care to establish an anonymised Wales wide Electronic Cohort for Children (WECC). WECC will serve as the platform for future work in translating information into child population health policy. There are 35,000 births in Wales per year, and data are available for the previous ten years. Thus, WECC will be sufficiently powered to answer important social, economic and health policy questions. WECC will also act as a demonstration project which would inform the development of e-cohorts to support translational research across the life course and disease spectrum.

NCT ID: NCT01125163 Completed - Clinical trials for Iron Deficiency Anemia

Trial Comparing Iron Supplementation Versus Routine Iron Intake in Very Low Birth Weight Infants

Start date: May 2010
Phase: N/A
Study type: Interventional

In preterm infants with birth weights less than 1500 grams, does iron supplementation with 2mg/kg/day in addition to routine feeding with routine iron-fortified milk (formula or fortified mother's milk), as compared to routine iron fortified milk, increase hematocrit at 36 weeks adjusted postmenstrual age (or at discharge if sooner)?

NCT ID: NCT01124331 Completed - Clinical trials for Bronchopulmonary Dysplasia

Appropriate Oxygen Levels for Extremely Preterm Infants: a Prospective Meta-analysis

NeOProM
Start date: March 2005
Phase: N/A
Study type: Interventional

The primary question to be addressed by this study is: compared with a functional oxygen saturation level (SpO2) of 91-95%, does targeting SpO2 85-89% in extremely preterm infants from birth or soon after, result in a difference in mortality or major disability in survivors by 2 years corrected age (defined as gestational age plus chronological age)?

NCT ID: NCT01115478 Completed - Anemia Clinical Trials

Malaria in Pregnancy: Nutrition and Immunologic Effects

MAL2
Start date: July 2010
Phase: N/A
Study type: Interventional

The purpose of this study is to determine the efficacy of zinc and/or vitamin A supplementation in reducing the risk of placental malaria and its associated adverse pregnancy outcomes.

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.

NCT ID: NCT01029353 Completed - Infant, Premature Clinical Trials

Laparotomy vs. Drainage for Infants With Necrotizing Enterocolitis

NEST
Start date: January 2010
Phase: N/A
Study type: Interventional

This study will compare the effectiveness of two surgical procedures -laparotomy versus drainage - commonly used to treat necrotizing enterocolitis (NEC) or isolated intestinal perforations (IP) in extremely low birth weight infants (≤1,000 g). Infants diagnosed with NEC or IP requiring surgical intervention, will be recruited. Subjects will be randomized to receive either a laparotomy or peritoneal drainage. Primary outcome is impairment-free survival at 18-22 months corrected age.