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Birth Weight clinical trials

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NCT ID: NCT02090088 Terminated - Low Birth Weight Clinical Trials

Nplate® Pregnancy Exposure Registry

NPER
Start date: May 2009
Phase: N/A
Study type: Observational [Patient Registry]

US study to estimate the prevalence at birth of major birth defects (ie, those that cause significant functional or cosmetic impairment, require surgery, or are life-limiting) in children born to mothers who have received Nplate® therapy at any time during the pregnancy.

NCT ID: NCT01851954 Terminated - Clinical trials for Very Low Birth Weight Infant

Pharmacokinetic Study of Clarithromycin in Very Low Birth Weight (VLBW)

Start date: February 2013
Phase: Phase 2
Study type: Interventional

The purpose of this study is to investigate the pharmacokinetics of clarithromycin which is used for premature infants with ureaplasma.

NCT ID: NCT01799629 Terminated - Clinical trials for Infant, Very Low Birth Weight

Efficacy of Prophylactic Glycerin Suppositories for Feeding Intolerance in Very Low Birth Weight Preterm Infants: a Randomized Trial

Start date: March 2013
Phase: N/A
Study type: Interventional

To evaluate the efficacy of prophylactic glycerin suppositories will accelerate the elimination of meconium from the large intestine and thus reduce the incidence of feeding intolerance in very low birth weight (VLBW) infants

NCT ID: NCT01795638 Terminated - Extreme Immaturity Clinical Trials

Sodium Supplementation and Growth in Very Low Birth Weight Infants

SSALT
Start date: October 2009
Phase: Phase 4
Study type: Interventional

Adequate growth during the neonatal period is critical for optimal long term outcomes. Despite maximal calorie intake, sixty percent of very low birth weight infants still fail to thrive suggesting that factors other than total calorie intake are important in ensuring consistent weight gain. Several reports have indicated a positive sodium balance is critical in ensuring good weight gain in very low birth weight infants, however these infants are susceptible to low serum sodium concentrations. Urine sodium values are sometimes used to diagnosis of hyponatremia or negative sodium balance after the first two weeks of life, but there is no evidence for this practice in preterm neonates. Our central hypothesis is that early supplementation with sodium will ensure positive sodium balance in very low birth weight infants and will result in optimal weight gain and enhanced long term outcomes. Secondarily we hypothesize that low sodium concentrations in the urine will not correlate with low serum sodium values.

NCT ID: NCT01788761 Terminated - Feeding Tolerance Clinical Trials

The Effects of Probiotic Supplementation on Extremely Low Birthweight Infants

Start date: July 2012
Phase: N/A
Study type: Interventional

This is a research study that will look at the effects of giving two nutritional supplements on extremely low birth infants (infants weighing less than 1000 grams or weighing less than approximately 2 lbs 3 1/2 ounces at birth). The nutritional supplements that will be studied are Culturelle for Kids/Culturelle Kids and Align. They are nutritional supplements that each contain a different probiotic. In this study the investigators will mainly be looking at the effect that these supplements may have on how well babies tolerate their feedings and how long they require supplemental intravenous fluids for nutritional support. The investigators will also, however, look at many other factors such as rate of growth, rates of infection, survival rate and the length of time the infant needs to be in the hospital. The investigators will also look at its effect on conditions/complications of prematurity such as bronchopulmonary dysplasia and chronic lung disease (chronic diseases of the lung associated with prematurity), necrotizing enterocolitis and intestinal perforations (serious diseases of the infant's intestines), retinopathy of prematurity (eye disease associated with prematurity), intracranial hemorrhage (bleeding into the brain) and patent ductus arteriosus (a blood vessel connecting two main blood vessels coming out of the heart that does not close spontaneously (by itself).

NCT ID: NCT01536483 Terminated - Clinical trials for Very Low Birth Weight Preterms

Effects of Recto-colic Enemas of Butyrate on the Digestive Disorders of Very Low Birth Weight Preterms <1250 Grams

NEOTRANS
Start date: February 2012
Phase: Phase 2/Phase 3
Study type: Interventional

Clinical management of very low birth weight newborns (VLBW <1250g) consists in several challenges to adapt immature physiological systems to extrauterine life. Advances in neonatal medicine for pulmonary and/or neurological and/or cardiovascular diseases have significantly improved outcomes of these children. However, the gastro-intestinal (GI) tract remains a major cause of morbidity due to 1. the immaturity of GI functions (prolonged ileus, bacterial overgrowth and translocation), 2. the complication of GI tract immaturity: intestinal perforation and enterocolitis necrotizing) 3. the need of a prolonged parenteral nutrition and its complications (central venous catheter infections, sepsis, electrolyte disturbances) but without generate a high proof level on this targeted population (<1250g). The GI functions are progressively acquired during development and are largely sensitive to the environment, especially the intestinal luminal content. Indeed, probiotics and prebiotics have shown beneficial effects upon GI functions of newborns. One of the metabolite of the gut flora potentially involved is the butyrate. Butyrate is a short chain fatty acid produced in the colon by the microbiota (carbo-hydrates degradation). The colonic amount of butyrate increases gradually after birth. The beneficial effects of butyrate are related to its properties upon the epithelial barrier (anti-inflammatory, antioxidant, barrier repair) and upon the enteric nervous system (network of neurons and glial cells) that regulate GI functions and in particular colonic motility. To date, there is no clinical consensus to manage digestive disorders of VLBW. Several clinical studies have assessed the effects of prokinetic drugs, dietary supplements (probiotics, prebiotics) but without generate a high proof level on this targeted population. In this context, a recent study of our Research Unit (INSERM-CIC Mère-Enfant 004) has shown benefit effects of oral probiotics supplementation in children with birth weight greater than 1000g but not in extreme preterms with birth weight less than 1000g. The main hypothesis to explain theses results lies in the intensive use of antibiotic and feeding interruption frequency in this targeted population which induce disturbances in the composition of the gut lumen (in particular the flora). Colonic enemas assessed in various observational studies concerning VLBW seem to demonstrate a clinical efficiency upon the colonic transit, underlying by mechanical and osmotic mechanisms. Here, the investigators propose to evaluate the clinical efficiency of butyrate enemas by a prospective randomized clinical trial blinded design. The purpose of NEOTRANS study is to demonstrate that butyrate enemas may improve the nutritional management of extreme preterm less than 1250 grams, by facilitating the development of colic motility and clinical nutrition tolerance.

NCT ID: NCT01434849 Terminated - Clinical trials for Very Low Birth Weight Infants

Timolol for the Prevention of Proliferation of Infantile Hemangioma (TiPPIH Trial)

TiPPIH
Start date: July 2012
Phase: Phase 1
Study type: Interventional

The purpose of this trial is to see if a topical beta blocker is effective in preventing the proliferation of infantile hemangioma.

NCT ID: NCT01430832 Terminated - Clinical trials for Post Traumatic Stress Disorder

Developmental Outcomes of Extreme Prematurity, 5-15 Years Postpartum

Start date: September 1, 2011
Phase:
Study type: Observational

The purpose of this study is to assess the emotional well being of mothers to preterm infants with ELBW 5-15 years after the birth. Post-traumatic symptoms and parental stress levels will be taken into consideration. In addition, the correlation between the infant's development and the mother's emotional state will be analyzed.

NCT ID: NCT01208493 Terminated - Prematurity Clinical Trials

Dietary Protein in the Very-low-birth-weight Infant

Start date: September 2007
Phase: N/A
Study type: Interventional

In this randomized study The investigators aim to compare the growth of very-low-birth-weight (VLBW) infants fed either a high protein or a standard protein preterm infant formula. Babies will be fed the assigned formula between the time they achieve full enteral feeds and hospital discharge, for a minimum of 3 weeks. The weight gain (g/d) will be measured and compared between groups. Feeding tolerance, protein-energy status and body composition between the study groups will also be analysed. After discharge, babies will be fed a post-discharge preterm infant formula (PDF) between hospital discharge and 3 m corrected age.

NCT ID: NCT01103219 Terminated - Clinical trials for Low Birth Weight Infant

Nutrition, Growth and Development Among Very Preterm Infants

PRENU
Start date: August 2010
Phase: Phase 3
Study type: Interventional

The main purpose of this study is to evaluate the effect of increased supply of energy, protein, vitamin A and the long chain polyunsaturated fatty acids docosahexaenoic acid and arachidonic acid on growth, brain maturation and cognitive function.