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Premature Birth clinical trials

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NCT ID: NCT02760472 Completed - Clinical trials for Retinopathy of Prematurity

A Fatty Acids Study in Preventing Retinopathy of Prematurity

DonnaMega
Start date: March 2013
Phase: Phase 3
Study type: Interventional

Most fatty acids, important for development and especially the Omega-3 fatty acids for the brain development are transferred in the third trimester with means that in the premature infant this transport via the placenta is interrupted and the infant is dependent on the concentrations in breast milk which vary depending on the mother's diet and her stores. It has even been suggested that low Omega-3 would be a cause of premature delivery. Many countries have much higher levels of Omega-3 fatty acids in breast milk than found in Sweden and breast milk substitutions are generally now supplemented with the Long Chained Poly Unsaturated Fatty Acids (LCPUFA). Therefore the supplementation to be given can not be seen to give any risks for the infant. On the contrary, several studies have shown that mother who eat equal to or less than twice fish a week during pregnancy give birth to infants with impaired development. Low Omega-3 levels in premature infants between gestational ages of 23 and 40 weeks can be one reason for Retinopathy of Prematurity (ROP) development. Restoration of Omega-3, Dokosahexaenacid (DHA) and Eikosapentaenacid (EPA) to normal in utero levels may prevent ROP by allowing normal vessel growth and survival. An increase of Omega-3 levels bringing levels to within physiological range may prevent development of ROP.

NCT ID: NCT02751437 Completed - Clinical trials for Preterm Infant Nutrition and Immune Function

Preterm Arginine INTake Study

PAINT
Start date: August 5, 2016
Phase: N/A
Study type: Interventional

The investigators will explore the effect of current intravenous feeding (parenteral nutrition (PN)) formulations on blood arginine levels and the genes that are involved in body nutrition and fighting infection in premature babies. They will also investigate the effect of supplementing arginine on these genes. The investigators will undertake a single centre exploratory physiological study in 12 very premature infants receiving PN. 4 of these infants will be supplemented with arginine. The investigators will record nutritional intake and routine biochemical testing data (which includes amino acid levels) collected over the first 10 days of life. They will take blood for analysis at prespecified intervals for microarray, ammonia and IGF-1 levels. Microarray findings will allow the investigators to describe the effect of arginine on gene activity in preterm infants.

NCT ID: NCT02745249 Completed - Premature Birth Clinical Trials

Assessing the Feasibility of Integrating Maternal Nutrition Interventions Into an Existing MNCH Platform in Bangladesh

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

Inadequate maternal nutrition is likely to undermine the potential impact of infant and young child feeding (IYCF) improvements made in the Alive & Thrive (A&T) first phase because it is linked to poor fetal growth leading to small-for-gestational age and pre-term newborns. These babies do not respond to growth promoting feeding practices as well as normal newborns do. In Phase 2, Alive & Thrive decided to focus on integrating a package of maternal nutrition interventions in a large-scale maternal, newborn and child health program (MNCH). This proposed evaluation aims to assess the feasibility of integrating maternal nutrition interventions into an existing MNCH platform in Bangladesh, using a cluster-randomized evaluation design.

NCT ID: NCT02743572 Completed - Premature Birth Clinical Trials

Iron-fortified Parenteral Nutrition in the Prevention and Treatment of Anemia in Premature Infants

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

The purpose of this study is to determine whether iron-fortified PN is effective in the preventative and treatment of preterm infants. Preterm infants are at risk for anemia especially in preterm infants. Anemia effects growing development, clinical prognosis, cognition, movement, learning ability and behavioral development. As enteral nutrition is not feasible soon after birth in most preterm infants, parenteral iron administration is an efficacious method for investigators to select. For most preterm infants, the use of parenteral nutrition(PN) is very common during the first ten days of life, so the investigators hypothesis that iron-fortified PN may have a preventative and treatment effect on preterm infants using PN as a supplementation of oral nutrition; Iron-fortified PN can also improve iron store status of preterm infants. The higher concentration of iron used in this study, the larger preventative or treatment effect on preterm infants anemia; it is safe to add small dose of iron agent to PN.

NCT ID: NCT02736136 Completed - Depression Clinical Trials

An Early Intervention to Increase Maternal Self-efficacy After Preterm Birth

JOIN
Start date: August 2016
Phase: N/A
Study type: Interventional

This study aims to investigate the effects of an early intervention (joint observation and video feedback) on maternal parenting self-efficacy following a premature birth. Mothers who have given birth to a very premature baby will be randomly allocated to either the early intervention or usual care whilst the infant is still hospitalized. Participants will be followed up at one month and six months. It is predicted that participants who received the early intervention will report higher maternal parenting self-efficacy than those who are not.

NCT ID: NCT02723552 Completed - Hypertension Clinical Trials

Trial of Exercise to Prevent HypeRtension in Young Adults

TEPHRA
Start date: June 23, 2016
Phase: N/A
Study type: Interventional

TEPHRA investigates the effect of exercise on blood pressure and other cardiovascular factors in young adults with different birth histories. TEPHRA will recruit 200 participants from 18-35 years old with elevated blood pressure (100 participants pre-term born and 100 full-term born). Half of the participants from each birth group will be randomised into a 16 week supervised aerobic exercise intervention trial and the other half will be controls. Participants will complete 3 main study visits: - Visit 1: Baseline visit conducted at beginning of study - Visit 2: 16 weeks into study (upon completion of structured exercise intervention for the exercise group) - Visit 3: End of study (52 weeks) Each visit will repeat the same set of cardiovascular measures including CPET, echo, blood pressure, vascular stiffness, and other measures. 50 participants from each group will complete an MRI sub-study of the heart, brain, and liver.

NCT ID: NCT02723513 Completed - Preterm Birth Clinical Trials

Bronchopulmonary Dysplasia: From Neonatal Chronic Lung Disease to Early Onset Adult COPD

Start date: April 1, 2016
Phase: N/A
Study type: Interventional

The investigators will apply xenon-129 (129Xe) and non-contrast enhanced magnetic resonance imaging (MRI) acquisition and analysis methods in 50 subjects aged between 20 and 29 years born pre-term (with and without a diagnosis of bronchopulmonary dysplasia [BPD]) and at term to characterize and probe the relationship between lung structure and function using imaging.

NCT ID: NCT02716909 Completed - Preterm Birth Clinical Trials

Pessary in Singleton Gestations With Short Cervix Without Prior Preterm Birth

Start date: March 2016
Phase: Phase 3
Study type: Interventional

Spontaneous preterm birth (SPTB) remains the number one cause of perinatal mortality in many countries, including the United States. In singleton gestations a short cervical length (CL) on transvaginal ultrasound (TVU) has been shown to be a good predictor of SPTB. The cervical pessary is a silicone device that has been used to prevent SPTB. The efficacy of cervical pessary has been assessed in several populations including singletons with short CL, unselected twins, twins with a short CL, and triplet pregnancies. Several randomized clinical trials (RCTs) have been published, and several are ongoing. However, no consensus on the use of cervical pessary in pregnancy or guidelines for management have been assessed.

NCT ID: NCT02710474 Completed - Premature Birth Clinical Trials

Family Nurture Intervention in the NICU

Start date: January 24, 2017
Phase: N/A
Study type: Interventional

The purpose of this study is to compare neurodevelopment and activity in infants born very preterm (26 to 33 6/7 weeks gestational age (GA)) receiving Standard Care (SC) or Family Nurture Intervention (FNI) in the neonatal intensive care unit (NICU). The study investigator hypothesizes that FNI will improve: i) neonatal electroencephalographic activity ii) maternal caregiving and wellbeing (psychological and physiological), and iii) infant behavior and neurodevelopment at 18 months corrected age (CA). The study aims to: - Replicate efficacy from an earlier trial by conducting the study at multiple sites to allow for greater generalizability. - SC, approximately 90 infants plus the parents - FNI, approximately 90 infants plus the parents - Term Controls, approximately 25 infants plus the parents

NCT ID: NCT02707731 Completed - Newborn Preterm Clinical Trials

Acute Effects of Neonatal Hydrokinesiotherapy in Newborn Preterm Hospitalized

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

This study aims to evaluate the acute effects of neonatal hydrokinesiotherapy in reducing stress in newborn preterm infants in the neonatal intensive care unit. Salivary cortisol samples were collected, pain applying the Neonatal Infant Pain Scale Scale (NIPS), heart rate, respiratory rate and oxygen saturation before and after hydrotherapy.