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Premature Birth clinical trials

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NCT ID: NCT03825835 Recruiting - Premature Infant Clinical Trials

30% or 60% Oxygen at Birth to Improve Neurodevelopmental Outcomes in Very Low Birthweight Infants

HiLo
Start date: June 27, 2022
Phase: N/A
Study type: Interventional

Preterm birth, or birth before 37 weeks' gestation, is increasingly common, occurring in 8 percent of pregnancies in Canada. Preterm birth is associated with many health complications, particularly when the birth happens before 29 weeks' gestation. At this gestational age, the lungs are not fully developed and it is not uncommon for infants to have problems breathing at the time of birth. One complication that can arise is when an infant stops breathing and needs to be resuscitated. When preterm babies need to be resuscitated doctors must take special care because of the small infant size and the immaturity of the brain and lungs. Oxygen is used to resuscitate babies who need it, but unfortunately there is disagreement about the best oxygen concentration to use. Oxygen concentration is important because both too much and too little oxygen can cause brain injury. This research aims to fill this knowledge gap by participating in an international clinical trial to compare the effects of resuscitating babies less than 29 weeks' gestational age with either a low oxygen concentration or a high oxygen concentration. The oxygen concentrations have been selected using the best available knowledge. This will be a cluster randomized trial where each participating hospital will be randomized to either 30 or 60 percent oxygen for the recruitment of 30 infants, and afterwards randomized to the other group for the recruitment of another 30 infants. After the trial, the investigator will determine whether the babies resuscitated with low oxygen or those resuscitated with high oxygen have better survival and long-term health outcomes. This research fills a critical knowledge gap in the care of extremely preterm babies and will impact their survival both here in Canada and internationally.

NCT ID: NCT03824782 Completed - Pain Clinical Trials

The Effect of Eyemasks on Neonatal Stress Following Dilated Retinal Examination

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

Although screening exams for retinopathy of prematurity (ROP) prevent blindness they are physiologically stressful for infants. The investigators postulate that photosensitivity during mydriasis contributes to post-examination stress and that reducing light stimulation with a phototherapy mask can make infants more comfortable. The objective of this study is to determine the effect of a phototherapy mask worn during mydriasis on infant stress in the 12 hour period following ROP screening.

NCT ID: NCT03819933 Recruiting - Premature Birth Clinical Trials

Optimizing Family Counseling for Anticipated Extremely Preterm Delivery

Start date: September 17, 2019
Phase: N/A
Study type: Interventional

Antenatal family counseling for anticipated extremely preterm deliveries remains ethically and practically challenging for maternal-fetal medicine specialists and neonatologists alike. The overall goal of this project is to improve antenatal counseling and counseling outcomes for families facing anticipated extremely preterm delivery through innovative, interdisciplinary simulation-based education for maternal fetal medicine specialists and neonatologists, using language preferred by families, and focusing on eliciting values and building partnerships through advanced communication and relational skills.

NCT ID: NCT03818867 Recruiting - Preterm Birth Clinical Trials

Emergency Cerclage in Twin Pregnancies at Imminent Risk of Preterm Birth: an Open-Label Randomised Controlled Trial

ENCIRCLE
Start date: May 15, 2017
Phase: N/A
Study type: Interventional

Twin pregnancies are at an increased risk of early delivery. One of the reasons for this may be due to a weakened neck of the womb (cervix). There are 2 main ways to manage a weakened cervix in pregnancy. One option is to do nothing (conservative approach). The other is to strengthen the cervix with a stitch (cerclage) to provide extra support. There is no good quality convincing evidence to suggest which of these has better outcomes for mum and babies in twin pregnancies. This trial aims to determine whether securing the weakened cervix with a cerclage will help to prolong the pregnancy and prevent early delivery. Babies who are born early experience multiple complications including lung, brain and learning difficulties. Therefore, the study will also aim to determine whether prolonging the pregnancy by inserting the cerclage reduces the number of babies affected by these problems. In order to carry out a fair study we aim to perform what is known as a randomised controlled trial. We will include in the trial two major groups: (1) women pregnant with twins, who present with a weakened cervix and no signs of infection between 14 and 26 weeks of pregnancy. This will be diagnosed on an internal examination or ultrasound scan, and (2) women pregnant with identical twins complicated by twin-to-twin transfusion syndrome (TTTS) treated by Laser surgery between 16 and 26 weeks in whom a short cervix (<15mm) is identified. TTTS is rare but potentially devastating condition which occurs in about 10-15% of identical twin pregnancies. If left untreated, 80-90% of these babies will die. Overall, best first-line treatment of TTTS is laser surgery. Cervical length is a strong predictor of preterm delivery in these pregnancies. Participants will be allocated randomly into the intervention (cerclage) or control (conservative) group. The procedure to insert the cerclage will be performed under an anaesthetic to minimise discomfort and you will be admitted for 2-3 days following the operation to ensure there are no complications or signs of labour. Women in both groups will be followed up in the same manner until they deliver and the pregnancy outcomes will be compared between the 2 groups to determine which management option is best.

NCT ID: NCT03816852 Suspended - Clinical trials for Premature Ovarian Failure

The Safety and Efficiency Study of Mesenchymal Stem Cell (19#iSCLife®-POI) in Premature Ovarian Insufficiency

Start date: October 1, 2018
Phase: Phase 2
Study type: Interventional

Evaluate the safety of human umbilical cord mesenchymal stem cells (hucMSCs) in POI treatment; Evaluate the effective hucMSCs in POI treatment. Compare different infusion mode, meanwhile compare with hormone replacement therapy (HRT) withdrawal, so that assessing the stem cell therapy.

NCT ID: NCT03814395 Active, not recruiting - Obesity Clinical Trials

Peking University Birth Cohort in Tongzhou

PKUBC-T
Start date: June 28, 2018
Phase:
Study type: Observational

The PKUBC-T is a prospective cohort study carried out in Tongzhou district of Beijing, China. The primary aim of this study is to investigate the short-term and long-term effects of pre-pregnant and prenatal exposure on maternal and child health. Data are collected regarding environmental, nutritional and lifestyle exposures as well as short-term and long-term health outcomes of mothers and their children from birth to 6 years old. Biological samples including blood and tissue samples are also collected from mothers and their children.

NCT ID: NCT03814278 Completed - Clinical trials for Preterm Premature Rupture of Membrane

Bed Rest After Preterm Premature Rupture of the Membranes

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

Antepartum bed rest is widely prescribed after preterm premature rupture of the membranes (PPROM), although its effectiveness to prevent preterm birth has not been demonstrated. This pilot randomized controled trial (RCT) aims to access the impact of bed rest in maternal and neonatal outcomes in pregnancies complicated by premature rupture of the membranes.

NCT ID: NCT03808051 Active, not recruiting - Preterm Infant Clinical Trials

Aeration, Breathing, Clamping Study 3

ABC3
Start date: January 25, 2019
Phase: N/A
Study type: Interventional

Delayed cord clamping (DCC) in preterm infants results in a decrease in mortality and a trend towards fewer intraventricular haemorrhages. However, preterm infants needing immediate interventions for stabilisation or resuscitation were generally clamped immediately and excluded from trials, while these infants might benefit the most of DCC. Studies in preterm lambs demonstrated that delaying cord clamping beyond ventilation onset resulted in more stable hemodynamic transition. This approach was called 'physiological-based cord clamping' (PBCC). The hypothesis of this study is that PBCC in preterm infants at birth will lead to an increase in intact survival when compared to standard care. This study is a multicentre randomised controlled, parallel design, superiority trial, including preterm infants less than 30 weeks of gestation. The intervention is PBCC: stabilisation of the infant with the umbilical cord intact and only clamp the cord when the infant is stable. Stable is defined as the establishment of heart rate greater than 100 bpm and oxygen saturation above 85% while using supplemental oxygen lower than 40%. In the control group cord clamping will be performed time-based: infants are clamped first (at 30-60 seconds if the clinical condition allows) and then moved to the resuscitation table for further stabilisation. The primary outcome will be intact survival at NICU discharge, defined as survival without cerebral injury (intraventricular haemorrhage ≥ grade 2 and/or periventricular leukomalacia ≥ grade 2 and/or periventricular venous infarction) and/or necrotizing enterocolitis (Bell stage ≥ 2).

NCT ID: NCT03798964 Completed - Preterm Birth Clinical Trials

The Expression Heparanase in Term and Preterm Placentas

Start date: January 23, 2019
Phase:
Study type: Observational

Heparanase is an endo-β-glucuronidase that cleaves heparin-sulfate (HS) side chains of heparan sulfate proteoglycans, an integral constituent of the extra cellular matrix (ECM). This study aims to investigate the association between heparanase expression in the human placenta and preterm birth (PTB) . The investigators hypothesize that an abnormal placentation causes relative placental ischemia that induces higher rates of heparanase expression.

NCT ID: NCT03796949 Completed - Preterm Birth Clinical Trials

Threatened Preterm Birth and Time of Subsequent Delivery -a Prediction Model

Start date: May 2014
Phase:
Study type: Observational

This study investigates immunological and clinical markers in threatened preterm birth aiming to create a prediction model for preterm birth.