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Premature Birth clinical trials

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NCT ID: NCT03083431 Recruiting - Clinical trials for Retinopathy of Prematurity

Oral Propranolol for Prevention of Threshold Retinopathy of Prematurity

RoProp
Start date: September 22, 2022
Phase: Phase 2
Study type: Interventional

Extremely premature infants are at risk of developing a potentially blinding eye disease, called retinopathy of prematurity (ROP). Currently available treatment, consisting of laser surgery or injection of drugs into the eye balls, may prevent most but not all cases of permanent ROP-mediated blindness. Both types of treatment are associated with significant costs and side effects. An orally administered drug commonly used to treat hypertension, propranolol, may be effective in halting progression of ROP to severe stages, as suggested by preliminary data from small studies. As severe (threshold) ROP is an overall rare disease, the effectiveness of propranolol in combating ROP can only be assessed in a large, multicenter randomized controlled trial involving hospitals caring for extremely preterm infants of diverse origin.

NCT ID: NCT03070158 Recruiting - Premature Infant Clinical Trials

Affective Bonding in Mothers and Their Premature Newborn

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

This experimental study will determine the effectiveness of nursing intervention "the attachment promotion" to increase the affective bonds between mothers and their premature infants. The assignment of the mothers to the control group will receive usual care, the mothers will be assigned to intervention group will receive the intervention.

NCT ID: NCT03062020 Recruiting - PreTerm Birth Clinical Trials

New Tool to Predict Risk of Spontaneous Preterm Birth in Asymptomatic High-risk Women

Start date: November 16, 2016
Phase: N/A
Study type: Interventional

The QUIPP tool integrates information of obstetrical history, quantitative fetal fibronectin (qfFN) and cervical length to predict the risk of sPTB in asymptomatic high-risk women. The aim of this study is to evaluate the QUIPP tool in our setting in order to optimize the management of women at high risk for sPTB and to validate in a randomized clinical trial, whether the use of QUIPP improves efficiently the management of our asymptomatic high-risk women when it is compared with the current clinical management. Design: Randomized controlled trial. Inclusion criteria: Asymptomatic singleton pregnancies 18,0-22,6 weeks at high-risk for sPTB. Sample size: According to a non-inferiority analysis, 129 pregnant women will be needed for each arm. Methodology: Patient selection and who consent to participate in the study will be randomized into two arms: a) Intervention group: QUIPP tool will be used to select and manage patients attending our PBPC: high-risk patients will be followed-up in our PBPC and low-risk patients will be discharged from PBPC and managed in a low-risk unit. b) Control group: Women will be managed according to current clinical practice. Main Outcome: sPTB <34,0 and <37,0 weeks of gestation. Secondary Outcomes: Pregnancy outcomes and a neonatal composite morbidity. Expected Results: Perinatal outcomes are similar in the intervention and control group although the intervention group using the QUIPP tool required less medical resources.

NCT ID: NCT03061864 Recruiting - Anxiety Clinical Trials

The Periviable Birth Plan

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

Pregnant women who are at risk of delivering their infants in the periviable period can suffer a large amount of stress and anxiety. Moreover, many women feel a loss of control over their own pregnancy. There is some evidence that more counseling and planning can help reduce maternal stress and anxiety. Patients at risk of delivering in the periviable period will be randomized to either receive standard counselling or to complete the periviable birth plan.

NCT ID: NCT03058536 Recruiting - Preterm Birth Clinical Trials

Progesterone and Cervical Pessary in Twins

PRECEPET
Start date: February 21, 2017
Phase: Phase 2/Phase 3
Study type: Interventional

The aim of this randomized control trial is to determine wheter cervical pessary plus vaginal progesterone (400mg) reduce preterm birth less than 34 weeks of gestacion and improve perinatal outcome, among women presenting asyntomatic short cervix, in twin pregnancy.

NCT ID: NCT03019692 Recruiting - Neonates Premature Clinical Trials

Longterm Outcome of Children With Neonatal Intra-Ventricular or Intra-Cranial Hemorrhage

NEONATAL ICH
Start date: January 2017
Phase: N/A
Study type: Observational

Intraventricular hemorrhage (IVH) is the most commonly recognized cerebral lesion on ultrasound in extremely preterm infants. Papile classification is commonly used to grade the severity of IVH. Grade III-IV IVH and other lesions noted on ultrasound including periventricular leukomalacia (pvl) porencephaly, and ventriculomegaly are well Documented to be associated with adverse neurodevelopmental outcomes. However, the true impact of lower-grade IVH on the neurodevelopment of these extreme preterm infants has not been well described. Also Neurodevelopmental outcome for neonatal non-traumatic Intra Cranial Hemorrhage (ICH) is not well established. The aim of this study is to look retrospectively at babies with neonatal IVH or ICH and follow their radiological, cognitive, motor and functional outcomes. The study will focus on postnatal files, and on images performed as part of the child's follow-up during hospitalization and after discharge.

NCT ID: NCT03013374 Recruiting - PreTerm Birth Clinical Trials

Protein Balance and Body Composition in Preterm Infants

Start date: January 2015
Phase: N/A
Study type: Observational

The adequacy of the quality of protein supply could influence the rate and the relative composition of weight gain in very low birth weight preterm infants. Aim of the study is to investigate protein balance according to feeding regimen and the association between human milk feeding and fat free mass content at term corrected age in a cohort of very low birth weight infants.

NCT ID: NCT03001492 Recruiting - Clinical trials for Premature Progesterone Rise

Does Premature Luteinization Matter?

Start date: December 2016
Phase: N/A
Study type: Observational

Elevation of serum progesterone on the day of ovulation triggering in IVF/ICSI cycles is suggested to be associated with compromized outcomes. Others found that this rise didnot affect the IVF/ICSI outcomes. It is still controversal if premature luteinization would affect the IVF/ICSI outcomes.

NCT ID: NCT02997345 Recruiting - Premature Birth Clinical Trials

PPROM Registry (Preterm Premature Rupture of Membranes)

Start date: July 2013
Phase:
Study type: Observational [Patient Registry]

Preterm Premature Rupture of Membranes (PPROM) before 37 weeks of pregnancy is responsible for 40% of preterm births in the United States. The PPROM Registry aims to identify possible causes of PPROM, evaluate trends in expectant management, measure maternal and fetal care, and to review short term and long term outcomes of affected pregnancies and births.

NCT ID: NCT02996799 Recruiting - PreTerm Birth Clinical Trials

Deferred Cord Clamping Compared to Umbilical Cord Milking in Preterm Infants

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

For preterm infants, deferred cord clamping has been shown to improve both short term and long-term neonatal outcomes without an established harm for both the mother and her infant.The interference with resuscitative measures for the neonate or the mother is a risk that continued to hamper the implementation of delayed cord clamping in many centers around the world.For that reason, the evidence now is seeking a time-honored, yet not adopted method of placental transfusion that involves milking of the umbilical cord.