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Premature Birth clinical trials

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NCT ID: NCT03438071 Completed - Clinical trials for Parent-Child Relations

Impact of Videoconference Updates in Neonatal Intensive Care Unit on Parental Stress of Preterm Infants (VISIO-NEONAT)

Start date: February 21, 2018
Phase:
Study type: Observational

The aim of the study is to test the effect of daily videoconference updates between parents of preterm newborns and health care providers which also offer them the possibility of seeing their child on the parental stress in a neonatal intensive care unit (NICU).

NCT ID: NCT03435263 Recruiting - Clinical trials for Management of Women With PROM at Term

Hospital Admission Versus Home Management in Women With Premature Rupture of Membranes :RCT

Start date: February 1, 2018
Phase: N/A
Study type: Observational

According to high tendency for admission of cases of premature rupture of membranes (PROM) for fear of maternal & fetal complications, we compare here between cases managed at hospital with other managed at home for if there any difference between in maternal and neonatal outcome.

NCT ID: NCT03433846 Completed - Sepsis Clinical Trials

Predictors of Sepsis in Ex-Preterm Infants

Start date: April 18, 2019
Phase:
Study type: Observational

The aims of this study are to: - Assess whether ex-preterm infants have a persistently immature immune system, which may decrease their ability to respond to infections, when they reach term-corrected gestational age. - Examine whether clinical history, nutrition status, and microbiome composition are linked to the immune composition of term and ex-preterm infants and whether these variables can be used to predict the risk of developing sepsis or having an immunologic disease.

NCT ID: NCT03433040 Completed - Premature Birth Clinical Trials

17OHP-C Dosing Among Obese Pregnant Women

Start date: August 23, 2017
Phase: Phase 3
Study type: Interventional

Emergency data suggest 17OHP-C may be less efficacious in obese women. Since obesity is associated with lower levels of plasma 17OHP-C, the investigator hypothesize that higher doses of 17OHP-C may help to prevent spontaneous PTB among obese women. The study aims to compare the pharmacokinetics of 17 OHP-C in obese compared with non-obese women.

NCT ID: NCT03432182 Recruiting - Sleep Clinical Trials

Body Movements Analysis During Sleep in Very Premature Infants

DODOPREMA
Start date: February 28, 2018
Phase: N/A
Study type: Interventional

Sleep is a key factor for normal brain development of the newborn. However, it is poorly studied and little is known about its characterization, especially in premature infants. Body movements during sleep are easy to evaluate but studies on their relationship to normal sleep states are scarce and limited. This project aims to characterize body movements during sleep, assessed by electroencephalography, in very premature infants. Then, a correlation between body movements, sleep organization and neurodevelopmental outcome will be evaluated at 3 years of age.

NCT ID: NCT03428685 Recruiting - Preterm Birth Clinical Trials

Progesterone to Prevent Preterm Delivery

Start date: January 15, 2019
Phase: Phase 2/Phase 3
Study type: Interventional

Preterm birth (PTB) is a major challenge to perinatal health. It is defined as delivery before 37 completed gestational weeks. It accounts for 75% of perinatal deaths and more than 50% of long-term neurological disabilities, and it is the second most common cause of death in children under the age of 5 year. Neonates born preterm are at risk of respiratory distress syndrome, chronic lung disease, retinopathy of prematurity, necrotizing enterocolitis, intraventricular haemorrhage and sepsis in the short term, as well as cerebral palsy, motor and sensory impairment, learning difficulties, and increased risk of chronic disease in long run. It is estimated that the societal cost of PTB is $26 billion annually in the USA alone. Until now, prevention or reduction of PTB is based on identification of risk factors in obstetrical history, biochemical markers and short cervix. History of PTB and asymptomatic short cervix at the second trimester are both strong predictors for PTB. In women with asymptomatic short cervix at the second trimester, vaginal progesterone could effectively reduce PTB. Universal cervical length screening followed by treatment with vaginal progesterone has been shown to be the most cost effective strategy in preventing PTB. These findings were confirmed in meta-analysis. Nevertheless, only minority of women may benefit from progesterone treatment if it was being started at the second trimester. There is still a large proportion of PTB, which is currently not preventable, and the current approach to prevent PTB is far from ideal. One possible hypothesis is that the initiation of progesterone treatment would be too late for its effect to take place. Therefore, we decide to use oral progesterone in the current study. The objective of the study is to determine whether early use of progesterone can prevent PTB better when compared with universal screening of cervical length and followed by treatment with progesterone in those with short cervix.

NCT ID: NCT03418870 Completed - Clinical trials for Premature Birth of Newborn

Improving Preterm Infant Outcomes With Family Integrated Care and Mobile Technology

mFI-Care
Start date: April 3, 2017
Phase: N/A
Study type: Interventional

The purpose of this study is to compare the standard of care in the neonatal intensive care unit (NICU), known as Family Centered Care, to a new model of care, called mobile enhanced Family Integrated Care. This exploratory two-group comparison study will examine the feasibility, acceptability and effectiveness, providing the first United States (US) information about outcomes of a new NICU care model that better integrates parents into all aspects of their baby's care. The use of mobile technology as part of this new model of care could improve access and equity in family integration for the many US families who face barriers to NICU involvement.

NCT ID: NCT03418311 Not yet recruiting - Preterm Birth Clinical Trials

Cervical Pessary Treatment for Prevention of s PTB in Twin Pregnancies on Children`s Long-Term Outcome

Impetus
Start date: September 2020
Phase: N/A
Study type: Interventional

Preterm birth (PTB) complicates 13% of all pregnancies worldwide and is the most important cause of neonatal morbidity and mortality. Women with a twin pregnancy are at increased risk of preterm delivery. In the Netherlands, approximately 50% of women with a multiple pregnancy deliver before 37 weeks of gestation (WoG), of whom 9% deliver before 32 weeks. Evidence based treatment guidelines concerning prevention of PTB are not available in Europe. Expectant management is usual care with interventions only in terms of a tertiary prevention of PTB according to guidelines for premature rupture of membranes, premature labour or other pregnancy complications. The studies done on this topic included women at different stages of the second trimester so the question of the onset of cervix shortening and its impact on PTB is not answered yet. The critical period for a maximum impact of the pessary treatment on PTB is still to be verified. Up to now only the ProTwinTrial addressed the long-term outcome of the newborns, so here data and evidence is clearly missing. The investigators want to assess the impact of a cervical pessary treatment in twin pregnancies with cervical shortening on children's survival without neurodevelopmental disability at the age of 3 years at 3 different stages of the second trimester (16-20 (early) vs. 20-24 (middle) vs. 24-28 (late) weeks of gestation).

NCT ID: NCT03418012 Not yet recruiting - Preterm Birth Clinical Trials

Prevention of sPTB With Early Cervical Pessary Treatment in Women at High Risk for PTB

Prometheus
Start date: September 2020
Phase: N/A
Study type: Interventional

Prevention of preterm birth (PTB) is a key factor for a positive short-term and long-term outcome of the newborn children as mortality and morbidity are inversely related to gestational age at delivery. Consequently every week of prolonged pregnancy will have a tremendous effect concerning the outcome of the new-borns, subsequently for their parents and society as well. The proposed RCT aims to evaluate the impact of a preventive pessary treatment on the prevention of preterm birth in women with a singleton pregnancy who are at high risk of spontaneous preterm birth (sPTB) due to a history of at least one previous preterm delivery and/or a history of previous cervical surgery. In accordance with the results by "van´t Hooft et al. 2016" an approximately 20% higher percentage of children's long-term survival without neurodevelopmental disability is expected for the pessary group in comparison with usual management (=control group) on basis of a reduction of prematurity < 34 week of gestation (WoG). The primary outcome measure for the effect of the pessary treatment in comparison to expectant management will be the children's long-term survival (3yrs) without neurodevelopmental disability. Secondary endpoints assess the impact of a preventive pessary placement on the prevention of preterm birth and its resulting risk on mortality and morbidity for the neonates.

NCT ID: NCT03414671 Completed - Clinical trials for Apnea of Prematurity

The Effect of Standardizing the Definition of a Clinically Significant Cardiopulmonary Event on Length of Stay

CSCPE
Start date: June 1, 2018
Phase:
Study type: Observational

A health care initiative will be implemented December 4, 2017 in the Newborn Intensive Care (NICU) setting in an attempt to reduce the length of stay (LOS) for premature infants after standardizing the definition and approach to a clinically significant cardiopulmonary event (CSCPE). We would like to compare LOS in infants born < 30 weeks gestation before and after standardization to see if LOS is reduced.