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Infant, Newborn, Diseases clinical trials

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NCT ID: NCT06267508 Not yet recruiting - Clinical trials for Infant, Newborn, Diseases

Increasing Neonatal HIV Test and Treat to Maximize the Long-Term Impact on Infant Health and Novel Infant Antiretroviral Treatment

LIFE2Scale
Start date: March 2024
Phase:
Study type: Observational

This study aims to improve HIV healthcare services for mothers living with HIV and their newborns in Tanzania and Mozambique. The main questions it aims to answer are: 1) does enhancing screening with maternal HIV viral load monitoring at delivery identify more mother-child pairs at high-risk for HIV vertical transmission? and 2) are high-risk infants linked to appropriate prevention and care? The study will expand access to HIV testing services to more rural settings using a hub-and-spoke referral system.

NCT ID: NCT06263790 Not yet recruiting - Clinical trials for Intubation; Difficult or Failed

Intubating Laryngeal Mask vs Direct Laryngoscopy: a Crossover Randomized Controlled Preterm Manikin Trial

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

The study aims to compare the success and time of intubation through an intubating laryngeal mask vs. direct laryngoscopy in a manikin simulating a term infant. In addition, we will assess the operator's opinion on the procedure. This is an unblinded, randomized, controlled, crossover (AB/BA) pilot trial of intubation procedure through intubating laryngeal mask vs direct laryngoscopy in a manikin simulating a term newborn.

NCT ID: NCT06255886 Not yet recruiting - Clinical trials for Gastroesophageal Reflux

Treatment of Gastroesophageal Reflux Disease in Infants

Start date: June 1, 2024
Phase: Phase 4
Study type: Interventional

Gastroesophageal reflux disease in infants is not fully understood. Infants are prescribed medical treatments that may not be effective or that contribute to adverse side effects and lead to concerns and expenses for the parents and healthcare system. Current guidelines recommend cow-milk-protein free diet as a first-line treatment, but these recommendations are based on weak evidence. This study investigate the efficacy of a cow-milk-protein free diet compared to treatment with a proton pump inhibitor (omeprazole)

NCT ID: NCT05954975 Not yet recruiting - Clinical trials for Infant, Newborn, Diseases

Baby Sickness Evaluation

BeSurE
Start date: September 2023
Phase:
Study type: Observational

The goal of this prospective single center feasibility study is to assess the feasibility of using BabyCheck and PO by GPs as an illness severity score for young infants > 6 months of age in order to aid the decision for referral to hospital. The emergency GP posts in Leiderdorp will add the BabyCheck and PO to their standard evaluation of infants presenting with systemic illness < six months of age for a period of six months. The feasibility will be determined by calculating the percentage of eligible infants in whom a complete BabyCheck score and PO data were retrieved. The investigators consider the protocol feasible if this is done in 80% of all eligible infants.

NCT ID: NCT05936112 Not yet recruiting - Clinical trials for Functional Gastrointestinal Disorders

Quantification of Fecal Calprotectin Concentration Difference Between Infants Aged Under 4 Months Old Suffering From Functional Gastrointestinal Disorders (FGID) and Infants Aged Under 4 Months Old Free From Disorders : a Transversal Case-control Monocentric Study

Cal-IBS
Start date: September 2023
Phase: N/A
Study type: Interventional

There is a high prevalence of FGID among infants : 30 % for regurgitations, 20 % for colitis , 15 % for functional constipation.This represents a frequent motive for pediatrics consultation : 23 to 28 % of medical consultations in this population are consequent to gastrointestinal symptoms among infants aged under 4 months old. This can lead to numerous inappropriate or unrecommended medication prescriptions. Currently, fecal calprotectin threshold are only validated by science societies for children aged 5 years old and more. This study aims to quantify the difference of fecal calprotectin between a population of infants for whom no FGID has been finally detected, and a population of infants for whom FGID have been detected during the gastro-pediatrics consultation, , in order to later determine wether it is possible to validate a threshold in a population of infants aged under 4 months old.

NCT ID: NCT05907317 Not yet recruiting - Hypoxia Clinical Trials

Safeguarding the Brain of Our Smallest Children-IIIv (SafeBoosC-IIIv)

SafeBoosC-IIIv
Start date: February 1, 2024
Phase: Phase 3
Study type: Interventional

The objective of the SafeBoosC-IIIv trial is to evaluate cerebral oximetry added to usual care versus usual care in mechanically ventilated newborns. The hypothesis is that the intervention will decrease a composite outcome of death or moderate to severe neurodevelopmental disability and/or increase the mean PARCA-R non-verbal cognitive score at two years of corrected age.

NCT ID: NCT05809063 Not yet recruiting - Neonatal Diseases Clinical Trials

Characterization, Risk Factors and Outcome of Neonates Admitted to Neonatal Intensive Care Units (NICU) at Sohag University Hospitals

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

The neonatal period considered the time from birth up to the first 28 days of life & further classified into: - Very early birth (birth to < 24 hours). - Early birth (24 hours to < 7 days). - Late or last neonatal period (7 days to 28 days). It is characterized by the transition from extra uterine life and rapid growth and development. It is the common vulnerable time or period of human life as it accounts for more high mortalities and morbidities, however, most of them are preventable. The pattern of neonatal disease is a useful indicator of the availability, utilization and effectiveness of maternal and child health care services. It varies from place to place and from time to time even in the same locality. Information on admission and mortality patterns of hospitalized neonates should reflect the major causes of illnesses and standard of care provided to neonates in a particular locality. To improve neonatal services with better overall outcomes and less sever morbidities early identification of the risk factors is paramount so that appropriate interventions can be directed towards the most prevalent and treatable neonatal illnesses. To achieve this goal, it is important to study the pattern of neonatal admissions

NCT ID: NCT05708105 Not yet recruiting - Clinical trials for Intraventricular Hemorrhage of Newborn Grade 2

Prediction of Intraventricular Hemorrhage Using Echocardiography and Near Infrared Spectroscopy

PIONIRS
Start date: April 2024
Phase:
Study type: Observational

Moderate-severe intraventricular hemorrhage (Grades II-IV, msIVH) is a significant neurological complication among extremely low gestational age neonates (ELGANs, <27+6 weeks) and is associated with long-term neurodisabilities. In Canada, msIVH affects ~25-30% of the 1300 ELGANs born annually, with little change in incidence over last decade. Typically, it occurs between days 2-7 of age, providing a finite window of opportunity. Instituting therapies at the population level, however, exposes many low-risk infants to side effects, adversely affecting risk-benefit profile and requiring large sample sizes in trials. A targeted preventative approach, though ideal, is currently challenged by our inability to reliably identify at-risk ELGANs early after birth. Near-infrared spectroscopy (NIRS) has emerged as a promising non-invasive bedside neuromonitoring tool. Pilot studies using NIRS, including ours, found lower cerebral saturations (CrSO2) and greater periods of altered cerebral autoregulation in infants who later developed msIVH. However, a systematic planned investigation is needed to establish the predictive characteristics of NIRS-derived markers, using clinically translatable methods (cumulative burden over time-period vs. single time-point values) and identify their relative performance at different time-points during transition. Further, incorporating echocardiographic (ECHO) hemodynamic markers, known to be associated with msIVH, may allow for the establishment of robust multi-model prediction models and the gain of mechanistic hemodynamic insights to inform future management. Hence, our objective is to investigate the utility of multi-modal assessment using NIRS and ECHO for early identification of ELGANs at risk of msIVH, and generate clinically applicable predictive model(s).

NCT ID: NCT05476055 Not yet recruiting - Premature Infants Clinical Trials

NGS in the Diagnosis of Neonatal Diseases

Start date: August 2022
Phase:
Study type: Observational

To investigate the application of NGS in neonatal disease screening and diagnosis, two studies was conducted (the other ID is: shercru-20220003). This study is to evaluate the application of NGS in the diagnosis of neonatal disease.

NCT ID: NCT04326361 Not yet recruiting - Neonatal Disorder Clinical Trials

A Survey of Neonatal Surgery Practices in India

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

The study will follow a cross-sectional survey design. The target population for the survey was neonatologists, paediatricians, paediatric surgeons and neonatal surgeons treating the newborn infants. The study will be nationwide survey of neonatal specialists regarding the common neonatal surgeries performed in the tertiary care teaching hospital in India. This cross-sectional survey study will commence once the project is approved by DST's Start-up Research Grant (SRG) approval committee and will continue for the period of two years. The protocol of this study was approved by the Institutional Ethics committee of the recognized tertiary care teaching university and will be conducted in accordance with the declaration of Helsinki guideline (Revised) 2013 and Indian Council of Medical Research guidelines 2017.