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Infant, Premature, Diseases clinical trials

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NCT ID: NCT06335524 Not yet recruiting - Child Development Clinical Trials

Infant-Maternal Partnership and Cognitive Training Study for Preterm Infants

IMPACT
Start date: September 2024
Phase: N/A
Study type: Interventional

This study will test the hypothesis that in preterm infants a caregiver-implemented early developmental intervention (EDI) using finger puppets to develop joint attention and encourage interactive communication with routine EDI care including Bookworm training compared with routine EDI care including Bookworm training alone will increase the Ages and Stages Questionnaire® score at 12 months corrected age.

NCT ID: NCT06145568 Not yet recruiting - Clinical trials for Infant, Premature, Diseases

Maternal & Infant Morbidity and Mortality

Start date: December 1, 2023
Phase:
Study type: Observational

The purpose of this project is to evaluate maternal and infant outcomes based on race at UVA hospital. Health inequities are influenced by a combination of Social, Political, and Clinical determinants of health. Our hypothesis is that patients with minority status, particularly Black and Hispanic Americans, are more likely to have poor outcomes (based on various health metrics) compared to Non-Black, Non-Hispanic patients. We hypothesize further that it is likely not far off from national trends, which indicate that Black parturients are x4 more likely to die during childbirth, and Black children are 2.4x more likely to die before their first birthday than Non-Hispanic White children. The EPIC database will be used on an institutional basis to obtain information and accessed by UVA statistician to perform the research described in this submission. The dataset does contain a few direct identifiers of medical record numbers, dates, and postal number. We anticipate that all statistical analysis will be performed at UVA by participating faculty/staff.

NCT ID: NCT05942924 Not yet recruiting - Clinical trials for Infant, Premature, Diseases

The NEU-STIM Trial

NEU-STIM
Start date: January 1, 2024
Phase: N/A
Study type: Interventional

The aim of this study is to determine the effect of repetitive tactile stimulation compared to selective stimulation on oxygenation of the infant at 5 minutes after birth. Infants born before 32 weeks of gestation will be included in this trial. This is a stepped-wedge cluster randomised controlled trial. The participating centre, rather than the individual infant, will be the unit of randomisation. This design is appropriate to test the effect of an intervention that encompasses a behavioral aspect - in this case the performance of tactile stimulation.

NCT ID: NCT05592431 Not yet recruiting - Clinical trials for Respiratory Tract Diseases

Effect of Volume Guarantee-High Frequency Oscillatory Ventilation on Cerebral Blood Flow in Neonates

Start date: October 27, 2022
Phase: N/A
Study type: Interventional

A randomized controlled clinical trial evaluates cerebral blood flow changes associated with HFOV-VG in comparison to HFOV alone in preterm neonates with respiratory insufficiency during the period of invasive respiratory support

NCT ID: NCT02326610 Not yet recruiting - Clinical trials for Infant, Premature, Diseases

Early hGH Treatment of SGA Infants to Prevent Irreversible Neurologic and Psychological Damage and Sequelae

hGH
Start date: December 2014
Phase: Phase 2
Study type: Interventional

SGA Infants who do not show a developmental catch-up growth within the first 6 months of life fall in the category of SGA children shown to have defects in the GH/IGF-I axis, resulting in partial hGH/IGF-I deficiency. Up to 1/4 of children born SGA have neurodevelopmental deficits. The partial hGH/IGF-I deficiency in SGA children can be the major or contributory cause of to their neurodevelopmental deficits To assess the effect of early growth hormone treatment given to symmetrical small for gestational age (SGA) infants not demonstrating catch-up growth on neurodevelopment and growth between birth and 6-12 months. The study is an innovative research not previously performed for improving neurodevelopmental outcome of SGA infants. As this is the first study of its kind, the safety of use of GH has not been reported, however based on multiple studies assessing use of GH in infants and young children, it is reasonable to similarly expect no short and long-term adverse effects. The study will take place at the Tel Aviv Medical Center only.

NCT ID: NCT01855347 Not yet recruiting - Hypoxia Clinical Trials

Evaluation of Abdominal Tissue Oxygenation in Premature Infants Using Near Infrared Spectroscopy

Start date: February 2016
Phase: N/A
Study type: Observational [Patient Registry]

There is an increasing incidence of Necrotizing Enterocolitis (NEC) affecting the premature infant population, principally those with associated risk like extreme prematurity, extreme low birth weight, associated co-morbidities (Congenital heart disease, perinatal asphyxia) and those born in hospitals with limited resources for optimal neonatal care. Near Infrared Spectroscopy (NIRS), has been used in premature infants to evaluate changes in cerebral perfusion and oxygenation. (1) It provides real time insight into the oxygen delivery.(3) In the premature patient population, many neurologic injuries occur as a result of prenatal (pre-existing) and/or postnatal disturbance on oxygen delivery. NIRS has been focused in cerebral monitoring. Light easily penetrates through neonatal bone and skin tissue, and allows to monitor the subjacent oxygen content. Early studies were performed to validate NIRS measurements and have established normative data.(4-6) The non-invasive method of monitoring cerebral hemodynamics and oxygenation has revolutionized the intensive care units in patients at risk for neurological injuries. This method has been successfully validated to monitor neonatal cerebral oxygenation in different clinical settings and study protocols. (7) NIRS provides non-invasive, continuous information on tissue perfusion and oxygen dynamics. One of the biggest challenges of NEC spectrum diseases is in the making of early diagnosis. It is important to monitor not just cerebral perfusion but also the intestinal oxygenation.(8,9) Previous studies with NIRS have demonstrated that premature infants change their cerebral - splanchnic oxygenation ratios during feedings.(10) Guy et al. performed NIRS in premature piglets to demonstrate association of perfusion change with NEC spectrum(11,12); these studies suggest evidence that NIRS could be a useful diagnostic tool in the premature infant population trough abdominal NIRS (a-NIRS) measurement capable of detecting alterations in intestinal oxygenation and perfusion. In summary, a-NIRS could be use in the premature infant population to define reference values, especially in patients at risk, which would then facilitate the early diagnosis of NEC spectrum diseases.