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Premature Birth clinical trials

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NCT ID: NCT03306316 Completed - Nutrition Clinical Trials

Prebiotic in Preterm Infants

Start date: July 4, 2018
Phase: N/A
Study type: Interventional

This is a double blinded, randomized, controlled trial of prebiotic in infants born between 26 and 32 weeks gestational age. The investigators anticipate enrollment of 90 subjects in total and for the study to be completed in 18 months. The investigators anticipate collecting clinical data, anthropometrics, stool samples (requiring appropriate storage through analysis), salivary samples from mother and infant, discarded blood samples from baby after the standard care lab tests are done, a single, optional blood draw at the conclusion of the study, and subjecting infants to a neurodevelopmental survey at study completion. The overall goal of this study is to test prebiotic administration to human milk-fed infants who are 700 gram to 1800 gram birthweight. The goal of this study will be addressed through one primary aim, a secondary aim, and exploratory aims, indicated below: Primary aim: Compare weight, length, and head circumference Z-score growth between the study and placebo groups. Secondary aim: Compare the time taken to achieve full feedings (135 mL/kg/day or more) between the study and placebo groups. Exploratory aim 1: Compare neurobehavior, as measured by the validated Neonatal intensive care unit Network Neurobehavioral Scale (NNNS), between the study and placebo groups. Exploratory aim 2: Compare fecal calprotectin levels to determine the impact of supplementation on reducing intestinal inflammation between the study and placebo groups. Exploratory aim 3: Compare fecal microbiome between the prebiotic and placebo groups, to determine whether there is a shift in microbial composition towards bifidobacteria and other microbes that are capable of metabolizing prebiotic.

NCT ID: NCT03304808 Completed - Clinical trials for Premature Ejaculation

Efficacy of a New Behavioral Treatment for Premature Ejaculation Using a Masturbation Aid Device: Star-Stop 3.0

Start date: October 1, 2017
Phase: N/A
Study type: Interventional

The present study included 57 patients ≥18 years who met diagnostic criteria for PE including intravaginal ejaculatory latency time (IELT) of ≤2 minutes and had a Premature Ejaculation Diagnostic Tool (PEDT) score ≥11. Subjects were randomized to an experimental group that used the device with exercise programme (n=18) a first control group that only used the exercise programme (n=17) and a wait-list control group (n=22). As a main outcome measure used stopwatch-measured average IELT, Premature Ejaculation Profile (PEP), and the Golombok-Rust Inventory of Sexual Satisfaction (GRISS).

NCT ID: NCT03304782 Completed - Preterm Birth Clinical Trials

Fitbit Activity Tracker to Predict Risk of Preterm Birth

Start date: October 24, 2017
Phase:
Study type: Observational

Almost half of all deliveries in the United States are of nulliparous patients. They have been identified as an at-risk population for preterm birth. Historically, the most significant risk factor for preterm birth is a prior history of preterm birth, which cannot be applied to a nulliparous population. Forecasting adverse outcomes in first time moms is difficult to predict and prevent. Historically, physicians have prescribed a restriction in activity level for those at risk for preterm delivery. The utility of this intervention has yet to be prospectively and quantitatively studied. The Fitbit activity tracker is a wearable device that has been extensively used in medical research, in an attempt to quantitatively identify how patient activity levels can improve medical outcomes. The study uses the Fitbit device in nulliparous patients, remotely track their activity levels throughout pregnancy, and assess pregnancy outcomes. Because of the significant and long-standing health disparity in the incidence of preterm delivery, the investigators will use the "Everyday Discrimination Scale", a validated battery of racism and health to see how a patient's stress related to perceived discrimination may modify the risk of preterm delivery.

NCT ID: NCT03303859 Completed - Bacterial Vaginosis Clinical Trials

Bacterial Vaginosis Carriage in Early Pregnancy and Preterm Delivery in Martinique, F.W.I

VaMap
Start date: December 18, 2013
Phase:
Study type: Observational

Preterm delivery is a public health priority in Martinique, a French oversees territory located in the Caribbean, with a rate of 10,5% substantially higher than in Continental France (7,5%). Bacterial vaginosis is an imbalance of vaginal flora known to be associated with preterm delivery risk. Studies driven in the United States have pointed out that 50% of the excess in preterm birth rate observed in Afro-American population compared to Caucasian population may be attributable to infection. Bacterial vaginosis appears much more prevalent in our population than in Continental France (approximatively 30% versus 7%) and may constitute an explanation to the discrepancy in preterm delivery rate.

NCT ID: NCT03302000 Completed - Preterm Infant Clinical Trials

Visual Stimulation of Preterm Infants

Start date: September 1, 2018
Phase: N/A
Study type: Interventional

Introduction: Prematurity rate has increased and is a risk factor for developmental delay. Preterm infants with low visual tracking might present deficits in cognition, language, and fine motor function in future ages. Few studies applied home stimulation of the visual system for preterm infant (PT) at an early age. Objective: To compare the effects of early visual stimulation to a standard care group in visual function, motor and sensory development. Methods: Randomized controlled trial. At home setting. Thirty healthy preterm infants, gestational age from 28 to 37 weeks, aged from one to two months of corrected age at the entrance of the study, with low visual function, will be evaluated. Participants will be randomly allocated to: (1) a standard care group, receiving orientation about general sensory and motor development, (2) an early visual stimulation group receiving a 4-week home based protocol applied by caregivers additional to standard care. Outcomes will be measured at before the beginning of stimulation, at the end of stimulation and at 6 months of corrected age. Primary outcome is visual function evaluated by ML Leonhardt Battery of Optotypes. Secondary outcomes include motor and sensory development evaluated by scales.

NCT ID: NCT03298347 Recruiting - Caffeine Clinical Trials

Caffeine for Preterm Infants With Apnea of Prematurity(AOP)

Start date: October 1, 2017
Phase: N/A
Study type: Interventional

Nowadays,caffein is commonly used for AOP, and it reduces the intubation rate in preterm infants. However, intubation is needed in about 20%-50% of partial neonates. How to reduce the intubation rate effectively is a challenge for neonatologists.

NCT ID: NCT03298191 Recruiting - Clinical trials for Preterm Labor Without Delivery

Tocolysis in Prevention of Preterm Labor

Start date: October 25, 2017
Phase: Phase 4
Study type: Interventional

Preterm birth is defined as birth before 37 completed weeks of gestation .it occurs in 11.1%of birth globally affecting an estimated 14.9 million babies every year . It is generally accepted that approximately 65%-70%of preterm births are spontaneous,40%-45% of them due to spontaneous preterm labor and 25%-30%following preterm rupture of membranes.preterm birth represents the single largest cause of morbidity and mortality for newborn and is estimated for 29%of deaths in the first four weeks of life and also is estimated for of major cause of morbidity for pregnant women . Tocolytic agents include a wide range of drugs that can slow or suppress uterine contractions . Tocolytic are considered advantages in spontaneous preterm labor to : (a) allow time for the fetus to mature ,potentially avoiding deleterious effects of pre-maturity . (b)allow time for antenatal corticosteroids to be administered and have clinical effect. (c) allow time for intrauterine transfer to higher-care center where neonatal intensive care facilities are available . the ideal Tocolytic agent should be effective , easy to administer , without significant material ,fetal or neonatal side effects and permit time for antenatal corticosteroids to be administered and take effect . a variety of Tocolytic treatments have been used to inhibit uterine activity in women in spontaneous preterm labor , including betamimetics , calcium channel blockers , magnesium sulfate , prostaglandin inhibitors and oxytocin receptor antagonists however there is considerable global variation in types , doses and regimens of tocolytic agents uses to manage preterm labor . A comparison study between Ritodrine, magnesium sulfate and Nifedipine in terms of effect and morbidity will be conducted.

NCT ID: NCT03297216 Completed - HIV-1-infection Clinical Trials

Improving Pregnancy Outcomes With Progesterone

IPOP
Start date: February 7, 2018
Phase: Phase 3
Study type: Interventional

This is a phase III, double-masked, placebo-controlled, randomized controlled trial taking place in Zambia.

NCT ID: NCT03292731 Terminated - Preterm Birth Clinical Trials

Relationship Between Plasma Concentration of Hydroxyprogesterone Caproate (17-OHPC) and Preterm Birth

PRO
Start date: February 12, 2018
Phase: Phase 1/Phase 2
Study type: Interventional

The study plans to determine the relationship between plasma concentrations of 17-OHPC hydroxyprogesterone caproate (17-OHPC) and the rate of preterm birth. The study is an open label study of pregnant women with one or more prior spontaneous preterm births who are receiving either 250mg of 500 mg of 17-OHPC as a weekly single injection. The safety of the 500 mg dose will also be assessed.

NCT ID: NCT03289936 Recruiting - Preterm Infant Clinical Trials

Short Term Effects of Synchronized vs. Non-synchronized NIPPV in Preterm Infants.

SyncNIV
Start date: November 16, 2020
Phase: N/A
Study type: Interventional

Comparing the cardio-respiratory adaptation and differences to non invasive ventilation techniques, nasal intermittent positive pressure ventilation (NIPPV) non synchronized vs synchronized (SNIPPV) in preterm newborns (gestational age at birth < 32 weeks) at their first approach to non invasive ventilation as first intention (soon after birth) or after extubation.