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Prematurity clinical trials

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NCT ID: NCT01784835 Completed - Prematurity Clinical Trials

Early Exposure to OMT Prevents Long LOS

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

The application of osteopathic manipulative treatment (OMT) in preterm infants has been demonstrated to be effective in reducing length of stay (LOS). The scope of the present study is to investigate the association between earlier exposure to OMT and reduction of LOS in premature infants

NCT ID: NCT01783041 Completed - Prematurity Clinical Trials

Effect of Early L-Carnitine Supplementation on Neurodevelopmental Outcomes in Very Preterm Infants

Start date: January 2013
Phase: Phase 2/Phase 3
Study type: Interventional

Preterm infants are vulnerable to brain injury, nutritional deficiencies and poor early growth which places them at increased risk for developmental problems later in life. The micronutrient carnitine, which is present in breast milk and stored in the fetus late in pregnancy, has been shown to protect against brain injury in animal studies. Without supplementation, almost all preterm infants develop carnitine deficiency soon after birth. Thus it is important to determine if carnitine supplementation protects against brain injury and improves developmental outcomes in these vulnerable preterm infants. We hypothesize that preterm infants supplemented early with L-carnitine while receiving parenteral nutrition will not develop carnitine deficiency and will have improved growth in the first two weeks of life and higher scores on developmental tests when compared to control infants who did not receive carnitine.

NCT ID: NCT01780155 Completed - Clinical trials for Bronchopulmonary Dysplasia

Genes Associated With Bronchopulmonary Dysplasia and Retinopathy of Prematurity

Start date: June 24, 2013
Phase:
Study type: Observational

Background: - Some premature babies develop bronchopulmonary dysplasia (BPD) and retinopathy of prematurity (ROP). BPD and ROP are long-term chronic diseases of the lungs and eyes, respectively. BPD is associated with receiving mechanical ventilation to treat respiratory distress syndrome, and causes lung inflammation and scarring. ROP is caused by poor development of blood vessels in the eyes, and may lead to blindness. Because not all premature babies develop BPD or ROP, researchers want to study the genes that could be associated with these diseases. They will look at both premature infants and their parents to see if there is a genetic component to BPD and ROP. Objectives: - To study genes that may be associated with BPD and ROP. Eligibility: - Premature babies born with a weight less than or equal to 1,250 grams. - Parents of the premature babies. Design: - Parents will answer questions about the mother s health and pregnancy. - Delivery and medical information will be collected during the baby s hospitalization for the first month after birth. - Parents will provide a saliva sample from the inside of the cheek. - A saliva sample will also be collected from the baby within 28 days of birth. If the baby needs tracheal aspiration (removal of fluid from the throat), tracheal fluid samples will also be collected. - Parents will have followup interviews about their child s health 6 months, 12 months, and yearly for up to 6 years after birth. - This is a genetic study only. Treatment will not be provided as part of this study.

NCT ID: NCT01776268 Completed - Prematurity Clinical Trials

Effect of Colostrum on Mucosal Immunity in Very Low Birth Weight (VLBWs) Premature Infants

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

Background: Infection in preterm infants is a common, costly, and devastating problem frequently causing death or sequelae for survivors. An immature immune system underlies the frequency and severity of infections in this vulnerable population. The mouth is the site where microbes first meet the mucosal immune system. Antimicrobial proteins and peptides (APPs) in saliva kill microbes and improve immune cell function. Low APP levels increase the risk of developing infection. Colostrum and human milk reduce the risk of infection. This protective effect of human milk may come from supplying or stimulating infant production of APPs. No prior investigation has determined the concentration of APPs in saliva or the effect of human milk/formula on the APP concentrations in saliva. Objective(s) and Hypothesis(es): The investigators objectives are to identify and serially determine the concentrations of key APPs in colostrum, human milk, and preterm infant saliva using highly-sensitive and specific mass spectroscopy methods. The investigators study is designed to test the hypotheses that (a) all saliva APPs increase over time, (b) APP concentrations are higher in colostrum as compared to human milk, and (c) APPs are increased in saliva of infants that receive colostrum orally compared to those that do not. Potential Impact: If increased saliva APP levels are associated with oral colostrum priming, this discovery would advance understanding of the immune properties of human milk and identify oral APPs as important immune elements and potential therapeutic targets in this vulnerable population. This knowledge has the potential to alter feeding practices and provide a safe, low cost means to improve immune function and significantly improve outcomes for preterm infants.

NCT ID: NCT01756040 Completed - Prematurity Clinical Trials

Intestinal Permeability in Preterm Infants

IPPI
Start date: February 1, 2013
Phase: Phase 1
Study type: Interventional

Necrotizing enterocolitis (NEC) is a life-threatening, gastrointestinal emergency characterized by increased intestinal permeability, affects approximately 7 to 10% of infants <1500 g birthweight, and typically occurs within 7 to 14 days of birth. Mortality is as high as 30-50%. Prematurity is the greatest risk factor for the development of NEC due to the physiological immaturity of the gastrointestinal tract and altered or abnormal gut microbiota. Several studies have demonstrated that the initiation of an intense systemic and local inflammatory cascade leads to intestinal necrosis. The human intestine is lined by a single layer of cells exquisitely responsive to multiple stimuli and is populated by a complex climax community of microbial partners. Under normal circumstances, these intestinal cells form a tight but selective barrier to "friends and foes": microbes and most environmental substances are held at bay, but nutrients are absorbed efficiently. Epithelial barrier integrity is itself dynamic and matures over time starting soon after birth, though the mechanisms regulating dynamic permeability are poorly understood. Low birth weight, prematurity, and early postnatal age are associated with a leaky gut. Although intestinal permeability is higher at birth in preterm than term infants, there is usually rapid maturation of the intestinal barrier over the first few days of life in both populations. The investigators hypothesize that increased levels of measures of intestinal permeability (urine lactulose/rhamnose (LA/Rh), and fecal alpha1- antitrypsin will identify infants at high risk for NEC and that intestinal probiotic strains will be associated with intestinal barrier maturation. The purpose of the study is to determine whether clinical factors in combination with non-invasive stool test such as antitrypsin (A1AT) and microbiota composition profile are associated with intestinal permeability determined by excretion of non-metabolized sugar probes in urine (LA/Rh ratio). These studies may lead to a non-invasive screening test to identify preterm infants at risk for NEC.

NCT ID: NCT01751724 Terminated - Respiratory Failure Clinical Trials

Caffeine to Reduce Mechanical Ventilation in Preterm Infants

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

Most premature infants require mechanical ventilation for prolonged periods of time and a significant proportion of them develop Bronchopulmonary Dysplasia (BPD). Caffeine is a stimulant of the respiratory center and has been used for the treatment of Apnea of Prematurity in infants not requiring mechanical ventilation or to facilitate weaning from mechanical ventilation by starting therapy shortly before extubation. Recently the use of Caffeine in ventilated infants has been initiated earlier because of the reported reduction in BPD. However there is paucity of data supporting this practice. Because protracted mechanical ventilation and supplemental oxygen increase the risk of developing BPD, a therapy that would facilitate the reduction of the respiratory support and shorten its duration is desirable. Therefore, it is of importance to evaluate the effects of early Caffeine initiation and administration during the course of mechanical ventilation in preterm infants by means of a randomized placebo-controlled trial. Hypothesis: The primary hypothesis of this study is that early use of caffeine in mechanically ventilated preterm infants will reduce the time to first elective extubation and secondarily, that this will reduce the total duration of mechanical ventilation and oxygen supplementation, and reduce the incidence and severity of BPD. Objective: The objective of this trial is to evaluate the effects of early caffeine use during mechanical ventilation on the time to first elective extubation, total duration of mechanical ventilation and oxygen supplementation, and the incidence of BPD. Study Design: This will be a single-center prospective, randomized, double-blind, placebo controlled clinical trial. Population: Premature neonates born between 23 and 30 completed weeks of gestation, who require mechanical ventilation within the first 5 days of life will be enrolled. Infants with major congenital anomalies or small for gestational age will be excluded. Methods: Infants will be randomized within the first 5 days to receive a study drug consisting of either blinded Caffeine citrate or blinded Placebo (equivalent volume of normal saline). Infants will continue to receive the study drug until the first elective extubation.

NCT ID: NCT01748565 Completed - Clinical trials for Bronchopulmonary Dysplasia

Gastrin-Releasing Peptide and Bronchopulmonary Dysplasia

GRP
Start date: May 2012
Phase:
Study type: Observational

The purpose of this study is to identify biological markers that might predict premature infants who are at a higher risk for developing BPD, and to correlate the presence of these markers with infant symptoms and lung function in the first year after discharge from the hospital.

NCT ID: NCT01746511 Completed - Prematurity Clinical Trials

Glycerin Suppositories to Reduce Jaundice in Premature Infants

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

The purpose of this study is to find out if giving glycerin suppositories will help decrease the length of time premature infants need phototherapy. The investigators hypothesize that glycerin suppositories (initiated along with phototherapy) will have no effect on reducing duration of phototherapy in premature infants with jaundice.

NCT ID: NCT01721629 Completed - Prematurity Clinical Trials

Weaning of Nasal Continuous Positive Airway Pressure (CPAP) in Premature Infants

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

The aim of this study is to investigate two different strategies for the withdrawal of CPAP in preterm infants born before 32 weeks of gestation.

NCT ID: NCT01697904 Completed - Oxidative Stress Clinical Trials

Trial of a Limited Versus Traditional Oxygen Strategy During Resuscitation in Premature Newborns

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

Preterm infants are born with immature lungs and often require help with breathing shortly after birth. This traditionally involves administering 100% oxygen. Unfortunately, delivery of high oxygen concentrations leads to the production of free radicals that can injure many organ systems. Term and near-term newborns deprived of oxygen during or prior to birth respond as well or better to resuscitation with room air (21% oxygen) compared to 100% oxygen. However, a static concentration of 21% oxygen may be inappropriate for preterm infants with lung disease.Purpose of the study is to investigate if preterm neonates where resuscitation is initiated with 21% fiO2 and adjusted to meet transitional goal saturations (Limited oxygen strategy or LOX) would have less oxidative stress as measured by the oxidative balance ratio of biological antioxidant potential/total hydroperoxide compared to infants where resuscitation is initiated with pure oxygen and titrated for targeted saturations of 85-94% (Traditional oxygen strategy or TOX). Secondary outcomes of interest included need for other delivery room resuscitation measures, respiratory support and ventilation/oxygenation status upon neonatal intensive care unit (NICU) admission, survival to hospital discharge, bronchopulmonary dysplasia and other short-term morbidities.