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Premature Birth clinical trials

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NCT ID: NCT05065385 Not yet recruiting - Prematurity Clinical Trials

The EveryPrem Project: Evaluating the INTER-NDA for Standardized Neurodevelopmental Screening at 2 Years of Age for Children Born Preterm.

EveryPrem
Start date: November 1, 2021
Phase:
Study type: Observational

Neurodevelopmental follow-up of infants at high-risk such as preterm born is necessary in order to early detect impairments and early start a supportive/therapeutic intervention. Valid tools should be available for screening infants with developmental problems even where resources are limited. Such screening would ensure an adequate medical care during and after hospital discharge as well as evidence-based parental pre- and postnatal counselling. While in Switzerland, these tools are specifically needed for the neurodevelopmental surveillance of moderate to late pretem born infants, in low- and mid-income countries, they are needed to monitor the whole population of preterm born infants. To fill this important gap, the present study aims to determine whether it is feasible to extend neurodevelopmental screening (currently offered to only a very small part of children born preterm), by using a new cost-effective neurodevelopmental assessment, the INTERGROWTH-21st Neurodevelopment Assessment (INTER-NDA, www.inter-nda.com Assessment) at age 2 years.

NCT ID: NCT05052879 Not yet recruiting - Clinical trials for Erectile Dysfunction

Efficacy and Safety of Toronto Association in the Treatment of Erectile Dysfunction and Premature Ejaculation

Start date: July 2024
Phase: Phase 3
Study type: Interventional

The purpose of this study is to evaluate the efficacy and safety of Toronto association in the treatment of both sexual dysfunction: erectile dysfunction and premature ejaculation.

NCT ID: NCT05044143 Not yet recruiting - Clinical trials for Preterm Labor With Preterm Delivery

Prediction of Preterm Delivery With Serial Cervical Length Measurements After Threatened Preterm Labor

Start date: September 20, 2021
Phase:
Study type: Observational

Prospective cohort study on pregnant women discharged from the hospital after the first episode of threatened preterm labor. Cervical length (CL) will be measured with transvaginal US upon initial presentation (i.e at the time of hospital admission), at the time of hospital discharge, and respectively 2, 4, 8 and 12 weeks later. Pregnant women undelivered after the 1st episode of threatened preterm labor will be invited to participate in the study if CL upon discharge is < 25 mm. The study will investigate the potential association between cervical shortening over time and time of delivery, to assess if spontaneous preterm delivery can be predicted by CL.

NCT ID: NCT05039918 Not yet recruiting - Pain Clinical Trials

Neonatal Experience of Social Touch

NEST
Start date: September 2021
Phase: N/A
Study type: Interventional

The purpose of this randomised control trial is to determine the efficacy of CT-optimal touch (gentle stroking at 3cm/s) for newborn's who require a heel prick.

NCT ID: NCT04922398 Not yet recruiting - Clinical trials for Premature Ovarian Failure

Ovarian Injection of PRP (Platelet -Rich Plasma) Vs Normal Saline in Premature Ovarian Insufficiency

Start date: June 20, 2021
Phase: Phase 1/Phase 2
Study type: Interventional

60 cases with premature ovarian insufficiency will be randomized to either receive PRP or saline injection in their ovaries. Then follow up by hormonal & ultrasound & clinically to monitor any changes

NCT ID: NCT04881695 Not yet recruiting - Clinical trials for Premature Ovarian Failure (POF)

Evaluation of Child Desire in Young Women With Premature Ovarian Failure

DESIOP
Start date: May 10, 2021
Phase:
Study type: Observational

Premature ovarian failure (POF) is a rare condition, affecting 1 in 10,000 women before age 20 and 1 in 1,000 women before age 30. The two main causes of POF are congenital and acquired. Patients with POF who carry out the desire to have a child turn to medically assisted reproduction through oocyte donation or to adoption. The main endpoint of this study is to compare the desire to have children among women with premature ovarian failure (POF) aged 18 to 26 years vs. controls of the same age (stratified by age) without major menstruation disorder.

NCT ID: NCT04878978 Not yet recruiting - Clinical trials for Threatened Preterm Labor

Premature Rupture Membranes and tPTL: a Personalised Approach (PROMPT)

PROMPT
Start date: September 1, 2021
Phase: N/A
Study type: Interventional

Preterm birth (less than 37 weeks) affect approximately 8% of babies in the UK and is the worldwide leading cause of death in children under the age of 5. Subclinical infection affects approximately 50% of women giving birth before 32 weeks. Infection contributes to significant neonatal morbidity and mortality. Antibiotics such as erythromycin is currently used to treat women who present with preterm rupture of membranes. While this has shown short-term improvement in neonatal morbidity, it has not had any impact in reducing the perinatal mortality and also little effect on the health of the children at age seven. Some antibiotics such as co-amoxiclav has not shown to be effective in delaying delivery and some studies have shown that antibiotics increases rather than reduces the risk of cerebral palsy. Many women do not display signs of infection and the underlying bacteria is multifactorial (bacterial vaginosis, trichomoniasis, gonorrhoea, Chlamydia, ureaplasma, Group B streptococcal and E. Coli) and remains a diagnostic challenge. The only available clinical approach is to test the sample of amniotic fluid for bacteria and small case series have shown prolongation of pregnancy when accurately targeted antibiotic treatment is used. This research aims to prove that targeted antibiotic therapy results in a greater prolongation of pregnancy than standard management for women with preterm prelabour rupture of membranes (PPROM) and/or threatened preterm labour (tPTL). Women will be randomised to standard care versus BioFire directed antibiotic treatment in addition to standard care. Investigators will use the BioFire point of care testing to identify the presence of infection and identify with anti-microbial resistance genes the bacteria possess to guide the antibiotic treatment. To be certain that the presence of infection is detected the investigators will use PCR to test the amniotic fluid for IL-6 and white cell count.

NCT ID: NCT04862377 Not yet recruiting - Clinical trials for Bronchopulmonary Dysplasia

Intratracheal Budesonide With Surfactant to Prevent Bronchopulmmonary Dysplasia.

BuS
Start date: October 1, 2021
Phase: Phase 3
Study type: Interventional

This study is designed to determine whether intratracheal administration of budesonide combined with surfactant, as compared to surfactant alone, will modify ecographic (lung ultrasound score) and biological markers (IL-6 concentration in respiratory secretions) at 7 days of life in preterm infants ≤32 weeks of gestational age (GA).

NCT ID: NCT04852094 Not yet recruiting - Prematurity Clinical Trials

Family-centered Round in Neonatology

VINCI
Start date: September 1, 2021
Phase:
Study type: Observational

The family-centered care is based on dignity and respect, information sharing, collaboration and participation in care and decision-making. In a neonatal unit, the medical round by the attending physician is an important moment for shairing information with the medical and nursing staff and for the decision making process. In France, parents are rarely actively involved in the medical round. The aim of this study is to plan the implantation of the Family-centered round in a neonatal department using the 6 steps of the "Intervention mapping": 1/needs assessment; 2/ performance and change objectives; 3/ theory-based framework; Curriculum development; 5- adoption and implementation; 6- evaluation and dissemination

NCT ID: NCT04820101 Not yet recruiting - RDS Clinical Trials

Dexmedetomidine for LISA Procedure in Preterm Infants

DEXLISA
Start date: May 15, 2021
Phase: N/A
Study type: Interventional

The investigators aim to evaluate: the effectiveness of dexmedetomidine for analgesia and sedation during LISA procedure, without compromising the respiratory drive; the safety of this drug on the preterm infant in a pilot study.