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Birth Weight clinical trials

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NCT ID: NCT01455636 Completed - Clinical trials for Infant, Low Birth Weight

Preventing Linear Growth Faltering Among Low Birth Weight Infants in Bangladesh

Start date: June 2010
Phase: Phase 3
Study type: Interventional

Low birth weight (LBW) infants are particularly vulnerable to frequent infections and consequent morbidity resulting in sub-optimal breastfeeding, limited ingestion of complementary foods and ultimately micronutrient deficiencies that result in post-natal linear growth faltering. The objective of this study is to facilitate improved feeding practices through the early reduction of infections using the innovative tools of water-based hand sanitizer (beginning at birth) and an improved micronutrient powder (I-MNP) (beginning at 6 months of age). A community-based cluster randomized controlled trial will be carried out in Bangladesh using a 2x2 factorial design. LBW infants (n=480) will be recruited at birth and allocated to either HS or No HS from 0 to 6 months. From 6 to 12 months, half of the children in each group will be randomized to receive I-MNP. All groups will receive nutrition and hygiene education from birth to 12 months. Recumbent length is the primary outcome; morbidity, dietary intake and hemoglobin will be assessed as secondary outcomes. By working with BRAC, the largest implementation agency in Bangladesh, there is the opportunity to translate the results directly and quickly into child health programs in Bangladesh.

NCT ID: NCT01443091 Completed - Clinical trials for Very Low Birth Weight Infants

Oropharyngeal Colostrum for Immune Stimulation in Very Low Birth Weight Infants

Start date: January 2011
Phase: N/A
Study type: Interventional

Colostrum, mothers' early breastmilk, contains multiple factors that provide immune protection to very low birth weight (VLBW) infants, a population at high risk for hospital-acquired infections. However, critical illness during the first few days of life often prevents the initiation of enteral feeds, placing these infants at even higher risk for morbidities including feeding intolerance and infection. Oropharyngeal administration has been proposed as an alternative route of delivery for colostrum and the immune benefits it provides. Research from animal and adult human models supports oropharyngeal administration as a potentially safe and effective mode of delivery for immune therapies. Immune components of colostrum, such as secretory IgA, may have both direct and indirect effects on the immune system. The purpose of this proposed randomized, placebo-controlled pilot study is to determine the effect of oropharyngeally administered colostrum (OAC) on immune stimulation in VLBW infants, as measured by secretory IgA (sIgA) levels. In addition to measuring sIgA response to OAC the investigators will also collect clinical data to determine if OAC has effects on tolerance of enteral feedings and rates of infection. The investigators hypothesize OAC will have a moderate effect on salivary secretory IgA concentration in VLBW infants. If proven efficacious, utilization of OAC in VLBW infants could have far reaching consequences for these highly fragile babies including lower rates of infection, improved tolerance of enteral feedings, and shorter NICU stays.

NCT ID: NCT01424553 Completed - Clinical trials for Bronchopulmonary Dysplasia

Respiratory Outcome at Adolescence of Very Low Birthweight Infants

EPIPAGEADO
Start date: October 2011
Phase: N/A
Study type: Interventional

EPIPAGEADO is an observational study. Respiratory symptoms and lung function will be evaluated in very low birth weight and term infants, born in 1997 and included in the French EPIPAGE cohort.

NCT ID: NCT01420029 Completed - Clinical trials for Low Birth Weight Neonates

Hospital-Based Phthalate Exposure in Very Low Birth Weight Neonates

Start date: August 2011
Phase: N/A
Study type: Observational

In this observational pilot project, the investigators plan to document duration and sources of exposure to plasticizers in infants born at birth weights less than 1500 grams. The investigators will examine the association between exposure to plasticizers and outcomes such as performance on a neurological screening tool, extrauterine growth, and thyroid function.

NCT ID: NCT01419873 Completed - Hyperglycaemia Clinical Trials

Study of a Model-based Approach to Blood Glucose Control in Very-low-birthweight Neonates

Start date: August 2008
Phase: Phase 4
Study type: Interventional

Very low birthweight neonates commonly develop high blood sugar levels. There is an association between high blood sugar levels and poorer short term outcomes but it is not known whether the high sugar level itself actually causes the problems. There are a range of ways to manage high sugar levels but there are no consensus guidelines to follow. One option is to manage the high sugar levels with an infusion of insulin. Studies looking at insulin infusions have often used fixed protocols to guide the amount of insulin to be given and are often complicated by hypoglycaemia. This study investigated whether using a model-based approach to individualise insulin administration to neonates with high sugar levels would provide a safe and effective management option for controlling blood sugar levels and avoid the complication of low blood sugar levels.

NCT ID: NCT01393496 Completed - Clinical trials for Anemia of Prematurity

Effects of Transfusion Thresholds on Neurocognitive Outcome of Extremely Low Birth Weight Infants

ETTNO
Start date: July 2011
Phase: Phase 4
Study type: Interventional

To compare the effect of restrictive versus liberal red blood cell transfusion thresholds on long-term neurodevelopmental outcome in extremely low birth weight infants.

NCT ID: NCT01390051 Completed - Clinical trials for Fetal Growth Retardation

Can Low Molecular Weight Heparin During Pregnancy With Intrauterine Growth Restriction Increase Birth Weight?

IUGR
Start date: July 2011
Phase: Phase 4
Study type: Interventional

The purpose of the study is to investigate if treatment with an anticoagulant drug increases birth weight in pregnancies complicated by fetal growth restriction.

NCT ID: NCT01385254 Completed - Clinical trials for Very Low Birthweight

Mother Sibling Interactions Following Very Low Birth Weight (VLBW) Infant Homecoming

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

The proposed study will explore longitudinally the impact of a very low birthweight (VLBW) infant on mother-sibling interactions and sibling adjustment. The study will also include a comparison group of fullterm infants to determine which sibling adjustment problems are typical of having a new baby in the home and which are associated with the unique stress of having a VLBW infant. This study will be the initial step in identifying factors affecting the adjustment of siblings of VLBW infants.

NCT ID: NCT01375309 Completed - Preterm Infants Clinical Trials

Bifidobacterium Supplementation for Very Low Birth Weight Infants

Bifido(RCT)
Start date: January 2010
Phase: N/A
Study type: Interventional

Probiotic supplementation to preterm infants have been reported to be beneficial in neonatal intensive care unit (NICU). Our pilot study also showed accelerated feeding in preterm infants who received Bifidobacterium bifidum early after birth. In order to evaluate these beneficial effects of Bifidobacterium bifidum, a prospective randomized control study is conducted. The hypothesis of the study is that Bifidobacterium bifidum supplementation to preterm infants improve enteral feeding and growth in very low birth weight infants.

NCT ID: NCT01363167 Completed - Clinical trials for Vitamin D Deficiency

Identifying Vitamin D Deficiency in Very Low Birth Weight Infant (VLBW) Infants Part 2

Start date: October 2011
Phase: N/A
Study type: Interventional

This study is to determine the amount of vitamin D required for a very low birth weight infant to reach vitamin D sufficiency and achieve optimal calcium health and bone growth.