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

Primary Purpose

Preterm Birth

Status
Completed
Phase
Not Applicable
Locations
Singapore
Study Type
Interventional
Intervention
Monitor Group
Sponsored by
KK Women's and Children's Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Preterm Birth focused on measuring end tidal carbon dioxide, mask ventilation, neonatal resuscitation

Eligibility Criteria

undefined - 60 Minutes (Child)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • KK Women's and Children's Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Monitor

Control

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Delivery room intubation
This outcome will be counted as yes if infant required endotracheal intubation in the delivery room
Delivery room chest compressions
This outcome will be counted as yes if infant required chest compressions in the delivery room
Delivery room peak inspiratory pressure (PIP)
Peak inspiratory pressure (PIP) used during mask ventilation during resuscitation after birth, measured as cmH20
Delivery room positive end expiratory pressure (PEEP)
Positive end expiratory pressure (PEEP) used during mask ventilation during resuscitation after birth, measured as cmH20
Delivery room fraction of inspired oxygen level (FiO2)
Fraction of inspired oxygen level (FiO2) measured using an oxygen analyser within the ventilating circuit during mask ventilation (ranges from 0.21-1.0)
Tidal volume during resuscitation
Tidal volume (ml/kg) measured using a respiratory function monitor sensor attached to the mask during mask ventilation
Mask leakage during resuscitation
mask leakage (%) measured and calculated using a respiratory function monitor during mask ventilation
Apgar Scores
Apgar score with a scale of 0-10 (0 being the worst and 10 the best) obtained by adding points for heart rate, respiratory effort, muscle tone, reflex, and colour to represent the condition of newborn baby after birth. Scores are assigned at at 1 and 5 minutes of life respectively, with extension after 10 minutes if initial scores are low
Admission blood gas partial pressure of carbon dioxide (pCO2) levels
first blood gas pCO2 levels in mmHg
Occurrence of air leak syndromes
pneumothorax, pneumomediastinum confirmed on x ray
Duration of assisted ventilation before discharge
ventilation days on mechanical ventilator or continuous positive airway pressure (CPAP) respectively
incidence of severe intraventricular hemorrhage (IVH)
ultrasound finding of grade3-4 intraventricular hemorrhage
incidence of necrotizing enterocolitis (NEC)
diagnosis of NEC proven by abdominal X-rays, classified as Bell Stage II
incidence of chronic lung disease (CLD)
diagnosed when there is a need for oxygen at 36 weeks post menstrual age
incidence of severe retinopathy of prematurity (ROP)
diagnosed when there is a need for laser surgery for treatment of ROP

Full Information

First Posted
February 19, 2020
Last Updated
October 3, 2023
Sponsor
KK Women's and Children's Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT04287907
Brief Title
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

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Completed
Study Start Date
June 6, 2019 (Actual)
Primary Completion Date
April 10, 2021 (Actual)
Study Completion Date
June 30, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
KK Women's and Children's Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Preterm Birth
Keywords
end tidal carbon dioxide, mask ventilation, neonatal resuscitation

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
50 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Monitor
Arm Type
Experimental
Arm Description
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.
Arm Title
Control
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
Monitor Group
Intervention Description
Use of colorimetric end tidal CO2 to guide provider during provision of mask ventilation, where colour change indicates effective breaths
Primary Outcome Measure Information:
Title
Bradycardia and Desaturation Duration
Description
Duration of bradycardia (HR<100beats per minute) + Desaturation (SpO2 readings below recommended target during respective minutes of life after birth
Time Frame
This outcome will be obtained immediately after birth when available on pulse oximetry
Secondary Outcome Measure Information:
Title
Delivery room intubation
Description
This outcome will be counted as yes if infant required endotracheal intubation in the delivery room
Time Frame
During resuscitation course at birth
Title
Delivery room chest compressions
Description
This outcome will be counted as yes if infant required chest compressions in the delivery room
Time Frame
During resuscitation course at birth
Title
Delivery room peak inspiratory pressure (PIP)
Description
Peak inspiratory pressure (PIP) used during mask ventilation during resuscitation after birth, measured as cmH20
Time Frame
During resuscitation course at birth
Title
Delivery room positive end expiratory pressure (PEEP)
Description
Positive end expiratory pressure (PEEP) used during mask ventilation during resuscitation after birth, measured as cmH20
Time Frame
During resuscitation course at birth
Title
Delivery room fraction of inspired oxygen level (FiO2)
Description
Fraction of inspired oxygen level (FiO2) measured using an oxygen analyser within the ventilating circuit during mask ventilation (ranges from 0.21-1.0)
Time Frame
During resuscitation course at birth
Title
Tidal volume during resuscitation
Description
Tidal volume (ml/kg) measured using a respiratory function monitor sensor attached to the mask during mask ventilation
Time Frame
During resuscitation course at birth
Title
Mask leakage during resuscitation
Description
mask leakage (%) measured and calculated using a respiratory function monitor during mask ventilation
Time Frame
During resuscitation course at birth
Title
Apgar Scores
Description
Apgar score with a scale of 0-10 (0 being the worst and 10 the best) obtained by adding points for heart rate, respiratory effort, muscle tone, reflex, and colour to represent the condition of newborn baby after birth. Scores are assigned at at 1 and 5 minutes of life respectively, with extension after 10 minutes if initial scores are low
Time Frame
During resuscitation course at birth
Title
Admission blood gas partial pressure of carbon dioxide (pCO2) levels
Description
first blood gas pCO2 levels in mmHg
Time Frame
During inpatient hospital course, usually 2-3 months
Title
Occurrence of air leak syndromes
Description
pneumothorax, pneumomediastinum confirmed on x ray
Time Frame
During inpatient hospital course, usually 2-3 months
Title
Duration of assisted ventilation before discharge
Description
ventilation days on mechanical ventilator or continuous positive airway pressure (CPAP) respectively
Time Frame
During inpatient hospital course, usually 2-3 months
Title
incidence of severe intraventricular hemorrhage (IVH)
Description
ultrasound finding of grade3-4 intraventricular hemorrhage
Time Frame
During inpatient hospital course, usually 2-3 months
Title
incidence of necrotizing enterocolitis (NEC)
Description
diagnosis of NEC proven by abdominal X-rays, classified as Bell Stage II
Time Frame
During inpatient hospital course, usually 2-3 months
Title
incidence of chronic lung disease (CLD)
Description
diagnosed when there is a need for oxygen at 36 weeks post menstrual age
Time Frame
During inpatient hospital course, usually 2-3 months
Title
incidence of severe retinopathy of prematurity (ROP)
Description
diagnosed when there is a need for laser surgery for treatment of ROP
Time Frame
During inpatient hospital course, usually 2-3 months
Other Pre-specified Outcome Measures:
Title
Number of corrective measures performed
Description
Number of corrective measures performed to overcome ineffective mask ventilation observed on video recording of resuscitation
Time Frame
During resuscitation at birth

10. Eligibility

Sex
All
Maximum Age & Unit of Time
60 Minutes
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Preterm infants 24+0/7 to 32+0/7 weeks who require mask ventilation during resuscitation Exclusion Criteria: Infants with impaired pulmonary circulation (eg. Cardiac arrest, pulmonary atresia, severe pulmonary stenosis Infants with congenital airway anomalies
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Juin Yee Kong, MD
Organizational Affiliation
KK Women's and Children's Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
KK Women's and Children's Hospital
City
Singapore
ZIP/Postal Code
229899
Country
Singapore

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
19255015
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.
Results Reference
background
PubMed Identifier
16801392
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.
Results Reference
background
PubMed Identifier
27939108
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.
Results Reference
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Use of CO2 Detectors to Help Provide Effective Breaths During Resuscitation of Preterm Newborns

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