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Death; Neonatal clinical trials

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NCT ID: NCT06087224 Recruiting - Morbidity;Newborn Clinical Trials

The TELENEO Trial: A Multicenter Trial of Telemedicine for Advanced Neonatal Resuscitations in Community Hospitals

Start date: March 5, 2024
Phase: N/A
Study type: Interventional

The purpose of this study is to evaluate the impact of real-time audio-video telemedicine consults with a neonatologist (termed teleneonatology) on the early health outcomes of at-risk neonates delivered in community hospitals.

NCT ID: NCT05960929 Not yet recruiting - Clinical trials for Intubation Complication

InfasurfAero™ Versus Sham Treatment in Preterm Newborns With RDS

Aero-05
Start date: July 1, 2024
Phase: Phase 3
Study type: Interventional

The purpose of this clinical study is to determine the effectiveness and safety of Infasurf® administered through the InfasurfAero™, a novel oral airway delivery device specifically designed to give Infasurf in a less complicated way and without the need for a breathing tube or interrupting nasal respiratory support.

NCT ID: NCT05397678 Recruiting - Morbidity;Newborn Clinical Trials

Trial to Compare BCG-Bulgaria and BCG-Denmark

BCGSTRAIN IV
Start date: October 21, 2022
Phase: Phase 4
Study type: Interventional

The trial will be a two-year outcome assessor-blinded RCT at the maternity ward of Hospital Simão Mendes (HNSM) in urban Bissau, Guinea-Bissau to compare vaccination with Bacillus Calmette-Guérin (BCG) Danish strain (AJ Vaccines, Copenhagen 1331 strain) versus BCG-Bulgaria (BB-NCIPD, BCG-SL 222 Sofia strain) 1:1 in 15,000 infants with respect to mortality, morbidity and case-fatality rate during hospital admission. The trial will also examine the association between BCG strains and BCG skin reaction kinetics and characteristics. As a secondary aim, this large study will be used to further evaluate the role of maternal BCG immune priming for overall health, since there are indications that the maternal BCG scar status influences offspring health outcomes.

NCT ID: NCT03997266 Recruiting - Clinical trials for Microbial Colonization

NICU Antibiotics and Outcomes Trial

NANO
Start date: August 5, 2020
Phase: Phase 4
Study type: Interventional

The goal of the NANO trial is to study the longstanding clinical practice of empirically administering intravenous antibiotics to extremely low birthweight (ELBW) infants in the first days of life. In this 802-subject multicenter placebo-controlled randomized clinical trial, the hypothesis to be tested is that the incidence of adverse outcomes is higher in babies receiving empiric antibiotics (EA) in the first week of life compared to babies receiving placebo. The study targets a population of ELBW infants in whom the clinical decision to use or not use EA is currently most challenging -- infants that are clinically stable that did not have a known exposure to intraamniotic infection and were not born preterm for maternal indications. The primary outcome is the composite outcome of late-onset sepsis (LOS), necrotizing enterocolitis (NEC), or death during the index hospitalization. Secondary safety outcomes will include total antibiotic days, days to full enteral feedings, and common morbidities in preterm infants that have previously been linked to EA, e.g. retinopathy of prematurity and bronchopulmonary dysplasia. Weight and length z-score, and head circumference, are standard measures to be collected weekly by clinical team per a standardized protocol.

NCT ID: NCT03770741 Completed - Brain Injuries Clinical Trials

Safeguarding the Brain of Our Smallest Infants Phase III

SafeBoosC
Start date: June 20, 2019
Phase: N/A
Study type: Interventional

the SafeBoosC-III trial investigates the benefit and harms of treatment based on near-infrared spectroscopy monitoring compared with treatment as usual. The hypothesis is that treatment based on near-infrared spectroscopy monitoring for extremely preterm infants during the first 72 hours of life will result in a reduction in severe brain injury or death at 36 weeks postmenstrual age.

NCT ID: NCT03019367 Completed - Death; Neonatal Clinical Trials

Premature Infants Receiving Milking or Delayed Cord Clamping: PREMOD2

PREMOD2
Start date: June 6, 2017
Phase: N/A
Study type: Interventional

This study is being done to find out whether umbilical cord milking (UCM) is at least as good as or better than delayed cord clamping (DCC) to reduce bleeding in the brain or prevent death in premature newborns. The investigators will study short and long term outcomes of infants delivered before 32 weeks gestation that receive either UCM or DCC. * The trial was stopped by the DSMB for safety in the small strata. They subsequently allowed for continuation of the trial in infants 29-32+6 wk GA.

NCT ID: NCT02811432 Completed - Preterm Infant Clinical Trials

Kangaroo Mother Care Before Stabilisation Amongst Low Birth Weight Neonates in Africa

OMWaNA
Start date: October 13, 2019
Phase: N/A
Study type: Interventional

We will conduct an individually randomised, controlled, superiority trial with two parallel groups; an intervention arm allocated to receive KMC and a control arm receiving 'standard' care. The primary aim is to examine the impact of KMC initiated before stabilisation on mortality within 7 days relative to standard care amongst neonates ≤2000g at four hospitals in Uganda. We hypothesise that neonates in the arm allocated to receive KMC before stabilisation will have a 25% overall reduction in mortality within 7 days compared to neonates allocated to receive standard care.