Use of CO2 Detectors to Help Provide Effective Breaths During Resuscitation of Preterm Newborns

NCT04287907 | Completed

• 1 other identifier: 2016/2405
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Preterm Birth

Keywords

end tidal carbon dioxide; mask ventilation; neonatal resuscitation

Outcome Measures

Primary Outcomes (1)

• Bradycardia and Desaturation Duration

  Duration of bradycardia (HR\<100beats per minute) + Desaturation (SpO2 readings below recommended target during respective minutes of life after birth

  This outcome will be obtained immediately after birth when available on pulse oximetry

Secondary Outcomes (15)

• Delivery room intubation

  During resuscitation course at birth

• Delivery room chest compressions

  During resuscitation course at birth

• Delivery room peak inspiratory pressure (PIP)

  During resuscitation course at birth

• Delivery room positive end expiratory pressure (PEEP)

  During resuscitation course at birth

• Delivery room fraction of inspired oxygen level (FiO2)

  During resuscitation course at birth

Other Outcomes (1)

• Number of corrective measures performed

  During resuscitation at birth

Study Arms (2)

Monitor

EXPERIMENTAL

Qualitative End Tidal Co2 detector will be attached to the face mask used to provide mask ventilation to the preterm baby before connected to the T piece resuscitator. Respiratory function monitor sensor will be placed within circuit to measure parameters e.g. PIP, PEEP, FiO2, tidal volume.

Device: Monitor Group

Control

NO INTERVENTION

face mask used to provide mask ventilation to the preterm baby will be connected directly to the T piece resuscitator. Respiratory function monitor sensor will be placed within circuit to measure parameters e.g. PIP, PEEP, FiO2, tidal volume.

Interventions

Monitor Group DEVICE

Use of colorimetric end tidal CO2 to guide provider during provision of mask ventilation, where colour change indicates effective breaths

Monitor

Eligibility Criteria

• Age: Up to 60 Minutes
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• KK Women's and Children's Hospital: lead

Study Sites (1)

KK Women's and Children's Hospital

Singapore, 229899, Singapore

Location

Related Publications (4)

• 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.

  PMID: 19255015 BACKGROUND

• 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.

  PMID: 16801392 BACKGROUND

• 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.

  PMID: 27939108 BACKGROUND

• Kong JY, Quek BH, Lim CSE, Sultana R, Ng YYV, Rajadurai VS, Yeo KT. Colorimetric CO2 Detector to Improve Effective Mask Ventilations in Very Preterm Infants: A Pilot Randomized Controlled Study. Neonatology. 2024;121(4):494-502. doi: 10.1159/000538083. Epub 2024 Mar 27.

  PMID: 38537615 DERIVED

MeSH Terms

Conditions

Premature Birth

Condition Hierarchy (Ancestors)

Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Study Officials

• Juin Yee Kong, MD

  KK Women's and Children's Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Consultant Neonatologist

Study Record Dates

• First Submitted: February 19, 2020
• First Posted: February 27, 2020
• Study Start: June 6, 2019
• Primary Completion: April 10, 2021
• Study Completion: June 30, 2022
• Last Updated: October 4, 2023

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will not share

Locations

SG (1)