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Prematurity clinical trials

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NCT ID: NCT05776238 Completed - Prematurity Clinical Trials

Lateral Position MRI in Preterm Infants, an Observational Study

MRIOPS
Start date: February 16, 2023
Phase:
Study type: Observational

The goal of this observational study is to evaluate safety of sedation in lateral position in premature babies undergone MRI. The main question it aims to answer are: - number of apneas during sedation - Maintenance of eupnea during deep sedation

NCT ID: NCT05765136 Recruiting - Prematurity Clinical Trials

Care Outcomes in Preterm Infants Following the Implementation of Family-centered Interventions

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

The proposed study evaluates the effects of two family-centered interventions on the length of stay and outpatient visits and growth of preterm infants.The interventions are 1) the Close Collaboration with Parents training for the staff and 2) moving from traditional neonatal intensive care unit architecture to single-family room architecture.

NCT ID: NCT05711927 Recruiting - Prematurity Clinical Trials

Sleep in SNOO Smart Sleeper Bassinet in Preterm Infants

Start date: March 16, 2023
Phase: N/A
Study type: Interventional

The goal of this clinical trial is to compare sleeping in a SNOO Smart Sleeper bassinet (SNOO) with sleeping in traditional bassinet conditions in premature infants. The main questions it aims to answer are: 1. Do preterm infants who sleep in the SNOO have more quiet sleep? 2. Do preterm infants who sleep in the SNOO have improved vital signs? - Participants will spend two separate three-hour periods sleeping in either a SNOO (which plays white noise and rocks from side-to-side) or in a SNOO that remains off (does not play white noise and does not move). There will be at least one week separating these sleep assessments. - Participants will have their sleep stage and vital signs monitored (heart rate and oxygen levels). - Participants will also wear two stickers on their forehead that measure brain oxygen levels (NIRS) and brain waves (EEG). There is a chance that the infant may experience more restful sleep and improved vital signs during the 2 sleep assessments.

NCT ID: NCT05694611 Not yet recruiting - Prematurity Clinical Trials

Preterm Neonates Brain Ultrasound With CEUS and Elastography

Start date: May 2023
Phase: Phase 3
Study type: Interventional

The aim of the study is to investigate levels of brain perfusion and elasticity in preterm neonates when they reach the estimated due date and to compare the data with magnetic resonance imaging at term. Contrast enhanced ultrasound (sulphur hexafluoride) and ultrasound-assisted elastography will be used to evaluate the state of brain perfusion with ultrasound. Different appropriate imaging sequences will be used regarding MRI, including asl-perfusion. Neonates recruited from the Neonatal Intensive Care Unit (NICU) of Turku University Hospital will be recruited.

NCT ID: NCT05675397 Recruiting - Prematurity Clinical Trials

Preterm Donor Human Milk Supplementation of Mother's Own Milk in VLBW Infants

Start date: December 1, 2022
Phase: N/A
Study type: Interventional

This prospective randomized controlled trial aims to investigate whether feeding very low birth weight (VLBW) infants with Mother's own milk (MOM) supplemented with either preterm (PDM) or term donor milk (TDM), when MOM is insufficient, has a positive impact on infants' protein intake, growth and morbidity.

NCT ID: NCT05646940 Completed - Prematurity Clinical Trials

Fact-based Nutrition for Infants and Lactating Mothers

NUTRISHIELD
Start date: October 1, 2020
Phase:
Study type: Observational

Human milk (HM) is the ideal source of nutrients for infants, but its composition is highly variable. When not enough own mother's milk (OMM) is available, the administration of pasteurized donor human milk (DHM) is considered the best alternative for feeding preterm infants (PI). The aim of this study is to evaluate the influence of diet, lifestyle habits, psychological stress, and pasteurization on the milk composition, and how it modulates infant's growth, health, and development. NUTRISHIELD is a prospective mother-infant birth cohort in the Spanish-Mediterranean area including three groups: PI <32 weeks of gestation (i) exclusively receiving OMM (i.e., >80% v/v of total intake), and (ii) exclusively receiving DHM, and (iii) term infants (TI) exclusively receiving OMM, as well as their mothers, and HM donors. Biological samples and nutritional, clinical, and anthropometric characteristics are collected at six time points covering the period from birth and until six months of infant's age (complete enteral nutrition (CEN) / recovery birth weight (RBW), and one, two, three, and six months). An additional assessment at two years (corrected age for PI) is conducted, in order to study long-term effects on neurodevelopment.

NCT ID: NCT05547139 Recruiting - Clinical trials for Bronchopulmonary Dysplasia

Impact of Extended CPAP on Bronchopulmonary Dysplasia

Start date: October 10, 2022
Phase: N/A
Study type: Interventional

The purpose of this pilot study is to compare if keeping infants on CPAP (continuous positive airway pressure) support for an extended period of time until they are 32 weeks corrected gestational age or 1250 grams (approximately 2 pounds and 12 ounces) will decrease their degree of lung disease as compared to weaning their respiratory support to HFNC (high flow nasal cannula).

NCT ID: NCT05537454 Recruiting - Prematurity Clinical Trials

Maternal Stress, Milk Composition, and Preterm Neurodevelopment

Start date: December 9, 2022
Phase:
Study type: Observational

This study explores the associations between maternal stress, breastmilk composition, and feeding and neurodevelopment for preterm infants in the NICU and at 4 months corrected age.

NCT ID: NCT05525585 Active, not recruiting - Prematurity Clinical Trials

Early Human Milk Fortification After Early, Exclusive, Enteral Nutrition in Very Preterm Infants

ENACT+
Start date: November 17, 2022
Phase: N/A
Study type: Interventional

In this proposed clinical trial, the investigators will randomize 80 very preterm (VPT) infants to receive either early (between day 4 and 7) or delayed (between day 10 and 14) fortification and determine if providing early protein supplementation through early fortification results in higher FFM-for-age z scores and more diversity in the gut microbiome.

NCT ID: NCT05508308 Completed - Prematurity Clinical Trials

Automated Versus Manual Control Of Oxygen For Preterm Infants On Continuous Positive Airway Pressure In Nigeria

Start date: September 13, 2022
Phase: N/A
Study type: Interventional

One in ten babies are born preterm (<37 weeks gestation) globally. Complications of prematurity are the leading cause of death in children under 5 years, with the highest mortality rate in Sub-Saharan Africa (SSA). Low flow oxygen, and respiratory support - where an oxygen/air mixture is delivered under pressure - are life saving therapies for these babies. Bubble Continuous Positive Airway Pressure (bCPAP) is the mainstay of neonatal respiratory support in SSA. Oxygen in excess can damage the immature eyes (Retinopathy of Prematurity [ROP]) and lungs (Chronic Lung Disease) of preterm babies. Historically, in well-resourced settings, excessive oxygen administration to newborns has been associated with 'epidemics' of ROP associated blindness. Today, with increasing survival of preterm babies in SSA, and increasing access to oxygen and bCPAP, there are concerns about an emerging epidemic of ROP. Manually adjusting the amount of oxygen provided to an infant on bCPAP is difficult, and fearing the risks of hypoxaemia (low oxygen levels) busy health workers often accept hyperoxaemia (excessive oxygen levels). Some well resourced neonatal intensive care units globally have adopted Automated Oxygen Control (AOC), where a computer uses a baby's oxygen saturation by pulse oximetry (SpO2) to frequently adjust how much oxygen is provided, targetting a safe SpO2 range. This technology has never been tested in SSA, or partnered with bCPAP devices that would be more appropriate for SSA. This study aims to compare AOC coupled with a low cost and robust bCPAP device (Diamedica Baby CPAP) - OxyMate - with manual control of oxygen for preterm babies on bCPAP in two hospitals in south west Nigeria. The hypothesis is that OxyMate can significantly and safely increase the proportion of time preterm infants on bCPAP spend in safe oxygen saturation levels.