Clinical Trials Logo
  1. Home
  2. Prematurity
  3. NCT05508308

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

Prematurity Clinical Trial

Official title:
Automated Oxygen Control for Preterm Infants On Continuous Positive Airway Pressure (CPAP): Phase 1/2 Trial In Southwest Nigeria

Clinical Trial Summary

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.

Clinical Trial Description

Trial description: A randomised cross-over trial of manual versus automated control of oxygen (OxyMate) for preterm infants on bCPAP. This trial will use an established technology (automated oxygen titration algorithm, VDL1.1) partnered with a low-cost bCPAP device in a low-resource setting. It will involve preterm infants requiring bCPAP respiratory support with allocation to OxyMate or manual oxygen control for consecutive 24 h periods in random sequence. Objectives: This trial seeks to examine safety and potential efficacy of our automated oxygen configuration (OxyMate) in preterm infants in a setting characterised by financial constraints, workforce limitations, and underdeveloped infrastructure, and assess contextual feasibility and appropriateness to inform future definitive clinical trials and product development. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT05508308
Study type Interventional
Source Murdoch Childrens Research Institute
Contact
Status Completed
Phase N/A
Start date September 13, 2022
Completion date September 29, 2023
View Details
See also
  Status Clinical Trial Phase
Recruiting NCT03670732 - CPAP vs.Unsynchronized NIPPV at Equal Mean Airway Pressure N/A
Completed NCT05322161 - Yoga in the NICU for Parents Study N/A
Recruiting NCT04542096 - Real Time Evaluation of Dynamic Changes of the Lungs During Respiratory Support of VLBW Neonates Using EIT
Recruiting NCT04911452 - Creating a Calmer NICU: Optimizing Growth and Brain Development in Preterm Infants N/A
Recruiting NCT02901652 - NIPPV and nBiPAP Methods in Preterm Infants With Respiratory Distress Syndrome N/A
Completed NCT02148965 - Effects of Exercise During Pregnancy on Maternal and Child Health: a Randomized Clinical Trial N/A
Terminated NCT02032511 - Comparison of RAM Cannula Nasal Continuous Positive Airway Pressure Versus Infant Flow Nasal Continuous Positive Airway Pressure (NCPAP) N/A
Completed NCT02273843 - A Trial on Different Dosages of Vitamin D in Preterm Infants With Late-onset Sepsis Phase 1
Completed NCT01721629 - Weaning of Nasal Continuous Positive Airway Pressure (CPAP) in Premature Infants N/A
Terminated NCT01819532 - Milking the Umbilical Cord Versus Immediate Clamping in Pre-term Infants < 33 Weeks N/A
Completed NCT00951860 - Assessment of Autonomic Maturation in Neonatal Period and Early Neural Development From a Longitudinal Prospective Cohort N/A
Completed NCT01478711 - Comprehensive Clinical Decision Support (CDS) for the Primary Care of Premature Infants N/A
Completed NCT01523769 - Umbilical Cord Milking on the Reduction of Red Blood Cell Transfusion Rates in Infants N/A
Completed NCT00749008 - Study of Generalized Movements for Early Prediction of Cerebral Palsy N/A
Completed NCT00787124 - Transfusions and Nitric Oxide Level in Preterm Infants
Terminated NCT01208493 - Dietary Protein in the Very-low-birth-weight Infant N/A
Completed NCT00527956 - Facilitation and Barriers to Breastfeeding in the NICU N/A
Terminated NCT00486395 - Will CPAP Reduce Length Of Respiratory Support In Premature Infants? Phase 3
Completed NCT03372590 - NEO Rehab for Infants at Risk of Cerebral Palsy N/A
Completed NCT00033917 - Indomethacin Germinal Matrix Hemorrhage/Intraventricular Hemorrhage (GMH/IVH) Prevention Trial Phase 3