Clinical trial NCT04287907: Use of CO2 Detectors to Help Provide Effective Breaths During Resuscitation of Preterm Newborns
Official title: The Utility of Qualitative End Tidal CO2 Detector in Providing Effective Ventilation During Resuscitation of Preterm Newborns: A Pilot Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Preterm Birth
Keywords: end tidal carbon dioxide
mask ventilation
neonatal resuscitation
Lead sponsor: KK Women's and Children's Hospital
Sponsor class: OTHER_GOV
First posted: 2020-02-27
Enrollment: 50
Sex: ALL
Maximum age (years): 60
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Effective ventilation is the single most vital intervention to improve outcome of resuscitation in the neonatal population. Assessments of effective ventilations are based on clinical parameters, but may be difficult due to inexperienced personnel as well as observer variability. End tidal CO2 detectors (ETCO2) have been shown to improve effective ventilation in manikin model as well as in video recordings of selective infants where obstructive breaths were recognized objectively by means of lack of colour change.

This is a trial evaluating the use of a qualitative end tidal CO2 monitor device during mask ventilation in the delivery room. The investigators hypothesize that using a colorimetric carbon dioxide detector during mask ventilation, it could facilitate recognition of obstructed breaths and reduce the duration of bradycardia and desaturations.


Eligibility criteria: Inclusion Criteria:

Preterm infants 24+0/7 to 32+0/7 weeks who require mask ventilation during resuscitation

Exclusion Criteria:

1. Infants with impaired pulmonary circulation (eg. Cardiac arrest, pulmonary atresia, severe pulmonary stenosis
2. Infants with congenital airway anomalies

Primary outcomes:
measure: Bradycardia and Desaturation Duration
timeFrame: This outcome will be obtained immediately after birth when available on pulse oximetry
Secondary outcomes:
measure: Delivery room intubation
timeFrame: During resuscitation course at birth
measure: Delivery room chest compressions
timeFrame: During resuscitation course at birth
measure: Delivery room peak inspiratory pressure (PIP)
timeFrame: During resuscitation course at birth
measure: Delivery room positive end expiratory pressure (PEEP)
timeFrame: During resuscitation course at birth
measure: Delivery room fraction of inspired oxygen level (FiO2)
timeFrame: During resuscitation course at birth
measure: Tidal volume during resuscitation
timeFrame: During resuscitation course at birth
measure: Mask leakage during resuscitation
timeFrame: During resuscitation course at birth
measure: Apgar Scores
timeFrame: During resuscitation course at birth
measure: Admission blood gas partial pressure of carbon dioxide (pCO2) levels
timeFrame: During inpatient hospital course, usually 2-3 months
measure: Occurrence of air leak syndromes
timeFrame: During inpatient hospital course, usually 2-3 months
measure: Duration of assisted ventilation before discharge
timeFrame: During inpatient hospital course, usually 2-3 months
measure: incidence of severe intraventricular hemorrhage (IVH)
timeFrame: During inpatient hospital course, usually 2-3 months
measure: incidence of necrotizing enterocolitis (NEC)
timeFrame: During inpatient hospital course, usually 2-3 months
measure: incidence of chronic lung disease (CLD)
timeFrame: During inpatient hospital course, usually 2-3 months
measure: incidence of severe retinopathy of prematurity (ROP)
timeFrame: During inpatient hospital course, usually 2-3 months
Other outcomes:
measure: Number of corrective measures performed
timeFrame: During resuscitation at birth
Locations:
city: Singapore
country: Singapore
facility: KK Women's and Children's Hospital
Study officials:
affiliation: KK Women's and Children's Hospital
name: Juin Yee Kong, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Finer NN, Rich W, Wang C, Leone T. Airway obstruction during mask ventilation of very low birth weight infants during neonatal resuscitation. Pediatrics. 2009 Mar;123(3):865-9. doi: 10.1542/peds.2008-0560.
citation: Leone TA, Lange A, Rich W, Finer NN. Disposable colorimetric carbon dioxide detector use as an indicator of a patent airway during noninvasive mask ventilation. Pediatrics. 2006 Jul;118(1):e202-4. doi: 10.1542/peds.2005-2493. Epub 2006 Jun 26.
citation: Hawkes GA, Finn D, Kenosi M, Livingstone V, O'Toole JM, Boylan GB, O'Halloran KD, Ryan AC, Dempsey EM. A Randomized Controlled Trial of End-Tidal Carbon Dioxide Detection of Preterm Infants in the Delivery Room. J Pediatr. 2017 Mar;182:74-78.e2. doi: 10.1016/j.jpeds.2016.11.006. Epub 2016 Dec 9.