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Premature Birth clinical trials

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NCT ID: NCT02508571 Active, not recruiting - Clinical trials for Premature Birth of Newborn

Direct Swallowing Training and Oral Sensorimotor Stimulation in Preterm Infants

Start date: July 2015
Phase: N/A
Study type: Interventional

This is randomized controlled trial investigating the effects of direct swallowing training and oral sensorimotor stimulation in preterm infants on oral feeding performance.

NCT ID: NCT02506725 Active, not recruiting - Pregnancy Clinical Trials

Quarenta Semanas: Innovative Intervention in Prenatal Care for Reduction of Prematurity

quarenta
Start date: August 2015
Phase: N/A
Study type: Interventional

The goal of Quarenta Semanas is to remove risk factors for preterm birth by linking women to prenatal care in the first trimester; supporting, educating and empowering women in pregnancy to reduce maternal stress and interrupt social, psychological, attitudinal and biological risk factors for preterm birth; and providing evidence-based, quality care that identifies and intervenes medically to treat underlying chronic and emergent conditions associated with preterm birth.

NCT ID: NCT02452580 Active, not recruiting - Clinical trials for Premature Birth of Newborn

The Norwegian Family Centered Care Study

Start date: September 1, 2013
Phase:
Study type: Observational

This study evaluates possible effects of two different NICU designs; by comparing traditional and Family Centered Care in terms of infant nutrition, health and growth, and coping by family.

NCT ID: NCT02392650 Active, not recruiting - Preterm Birth Clinical Trials

Microbiome And Multi'Omics In Preterm Birth: The Bacteria And Birth Study

BaBs
Start date: June 2014
Phase:
Study type: Observational [Patient Registry]

Hominids and hominins serve as remarkable hosts to microbes, and we have co-evolved over the past 4.5 million years as highly plethoric communities. Human-associated microorganisms (the "microbiome") are present in numbers exceeding the quantities of human cells by at least 10-fold beginning in the neonatal period. The collective genome (the "metagenome") exceeds our human genome in terms of gene content by more than 150-fold. With respect to microbiota and preterm birth, it has generally assumed that the majority of intrauterine infections originate in the lower genital tract, with microbiota ascending into the otherwise sterile intrauterine environment to infect the placenta (preterm birth), fetal membranes (chorioamnionitis), umbilical cord (funisitis), and the fetus (sepsis). However, we and others have recently demonstrated that the vaginal and gut microbiome communities are distinctly structured in pregnancy, and the placenta is in fact not sterile, but rather harbors a low-abundance microbiome which is likely acquired through hematogenous transmission of the oral microbiome. Based on our prior studies and preliminary data, our central hypothesis is that a distinct and largely commensal resident microbiome in pregnancy renders risk for preterm birth. By utilizing our state-of-the-science technology and analysis tools in a longitudinal case-cohort of preterm birth subjects, we will be able to transform "discovery based" metagenomics and multi'omics science into readily translatable mechanistic studies at a previously unparalleled level.

NCT ID: NCT02372942 Active, not recruiting - Preterm Delivery Clinical Trials

Lactoferrin or Progesterone for Prevention of Preterm Delivery

Start date: February 2014
Phase: Phase 4
Study type: Interventional

Primary endpoint will be evaluate the effectiveness of vaginal lactoferrin in the reduction of the 30% of preterm deliveries versus the use of progesterone, in specific selected patients, with consequent improvement in neonatal outcome. Secondary endpoint will be compare antibacterial and anti-inflammatory activity of lactoferrin by evaluation of systemic biochemical and urinary markers.

NCT ID: NCT02179996 Active, not recruiting - Clinical trials for Pertussis Immunisation in Very Preterm-born Infants

Diphtheria, Tetanus, Poliomyelitis -Pertussis-Hib Immunisation in Preterm-born Neonates

VacciPrema
Start date: January 2014
Phase: Phase 4
Study type: Interventional

Preterm neonates are fragile to infections. Their immune system is immature, yet in France, primary vaccines are injected at two months of age, as in term infants. Recommendations for vaccinations in infants have changed in France in 2013, suppressing the second injection at three months after birth. Preterm and full-term born infants are now vaccinated at two and four months of age, but no data regarding efficacy in very preterm infants have been registered. The investigators hypothesize that two vaccine injections (at two and four months) would be less efficient than three injections (two, three and four months) in very preterm-born infants.

NCT ID: NCT02159534 Active, not recruiting - Preterm Infants Clinical Trials

Primebrain Stimulation

Start date: September 2014
Phase: N/A
Study type: Interventional

Background : Brain vulnerability is particularly marked in preterm neonates and has long-term consequences. Unlike lesions affecting other organs, those that affect the brain can currently not 'be repaired' by producing new cells. However, exeprience-driven brain plasticity allows the brain to reorganise its connections to compensate (at least partially) the effects of an injury. Purpose : To evaluate the influence of Primebrain stimulation programme administred by parents until 6 months post-term on motor and neurophysiological development of infants born <32 weeks' gestation or with birth weight <1500 g.

NCT ID: NCT02108886 Active, not recruiting - Preterm Labor Clinical Trials

Pilot Study Testing a New Strategy for Management of Spontaneous Preterm Birth

EAU2-Mtlk
Start date: December 2011
Phase: Phase 2
Study type: Interventional

Preterm birth is a major public health problem, and actual treatments are not very efficient. The purpose of this study is to test the efficiency of a combined use of Montelukast and Nifedipine to treat preterm labor. Investigators aim to reduce uterine contractions more efficiently than with the use of Nifedipine only.

NCT ID: NCT02024854 Active, not recruiting - Premature Birth Clinical Trials

Skin-to-skin After Delivery in Preterm Infants Born at 28-32 Weeks of Gestation

Start date: February 1, 2014
Phase: N/A
Study type: Interventional

The aim of the study is to investigate physiological response, social/emotional response and general movements in preterm infants when they are given skin-to-skin contact with the mother (intervention) or standard care (incubator) right after delivery. Preterm infants will be randomized to either intervention or standard care group. Data on body temperature, blood glucose, hart rate, respiration rate and oxygen saturation will be obtained. In addition the infant will be video-recorded during the first 24 hours and at three months of age for analysis of the general movements.

NCT ID: NCT01852695 Active, not recruiting - Premature Birth Clinical Trials

Family Integrated Care in the NICU

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

In the highly technological environment of the modern neonatal intensive care unit (NICU), the infant is physically, psychologically and emotionally separated from its parents. Recognition that this impedes parent- infant interaction and is detrimental to the infant, led to the development of programs such as family centered care, kangaroo care and skin-to-skin care1-3. However, they are based on the common premise that only NICU professionals with special skills can provide care for the infant. Parents are relegated to a supportive role, and some have described themselves as voyeurs who are "allowed" to visit and hold their infants4. Many feel anxious and unprepared to care for their infants after discharge5. In 1979, a shortage of NICU nurses in Estonia prompted Levin1,6 to implement a "humane" care model in which parents provided nursing care for the infant (except for administration of IV fluid and medication), while nurses provided teaching and guidance to parents. This resulted in 30% improvement in weight gain1,30% reduction in infections, 20% reduction in NICU length of stay, 50% reduction in nurse utilization and overall improved satisfaction among parents and staff [personal communication, Levin,A.]. Building on the Estonian experience, we have developed a new Family Integrated Care (FIC) model that is adapted for the NICU environment in North America. In a pilot study at Mount Sinai Hospital, Toronto 46 infants and their families were enrolled in the study. Preliminary results and feedback from parents and healthcare providers (HCP) show that the FIC model is both feasible and safe, and may lead to improved outcomes including improved weight gain(paper submitted for publication). This study is a cluster randomized controlled trial in 16 tertiary level NICUs, to evaluate the efficacy of the FIC model in Canada.