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Preterm BirthNCT04287907

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

A study testing Monitor Group in people with Preterm Birth, run by KK Women's and Children's Hospital at 1 site in Singapore.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages Up to 60 minutesHealthy volunteers can take part
Conditions the study is for
Preterm Birth
What is being tested?
Monitor Group
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
50 participants
Where
1 siteSingapore
Study dates
6 Jun 2019to 30 Jun 2022
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages Up to 60 minutes
  • All sexes
  • Healthy volunteers accepted
  • Child

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

Singapore1 site

  • KK Women's and Children's Hospital

    Singapore, 229899

Other trials in Singapore

About this study

Official title: The Utility of Qualitative End Tidal CO2 Detector in Providing Effective Ventilation During Resuscitation of Preterm Newborns: A Pilot Randomized Controlled Trial

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
Being tested
Monitor Group
Keywords
end tidal carbon dioxide, mask ventilation, neonatal resuscitation
Medical subject headings
Premature Birth

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Monitor GroupDevice

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

Study groups in NCT04287907
Study groupRoleWhat they receive
MonitorExperimentalQualitative 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.
Receives: Device: Monitor Group
ControlNo interventionface 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.

What is being measured

The primary outcome is the main question the study is designed to answer.

  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

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

Secondary outcomes (15)

  1. Delivery room intubation

    This outcome will be counted as yes if infant required endotracheal intubation in the delivery room

    Measured: During resuscitation course at birth

  2. Delivery room chest compressions

    This outcome will be counted as yes if infant required chest compressions in the delivery room

    Measured: During resuscitation course at birth

  3. Delivery room peak inspiratory pressure (PIP)

    Peak inspiratory pressure (PIP) used during mask ventilation during resuscitation after birth, measured as cmH20

    Measured: During resuscitation course at birth

  4. Delivery room positive end expiratory pressure (PEEP)

    Positive end expiratory pressure (PEEP) used during mask ventilation during resuscitation after birth, measured as cmH20

    Measured: During resuscitation course at birth

  5. 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)

    Measured: During resuscitation course at birth

  6. Tidal volume during resuscitation

    Tidal volume (ml/kg) measured using a respiratory function monitor sensor attached to the mask during mask ventilation

    Measured: During resuscitation course at birth

  7. Mask leakage during resuscitation

    mask leakage (%) measured and calculated using a respiratory function monitor during mask ventilation

    Measured: During resuscitation course at birth

  8. 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

    Measured: During resuscitation course at birth

  9. Admission blood gas partial pressure of carbon dioxide (pCO2) levels

    first blood gas pCO2 levels in mmHg

    Measured: During inpatient hospital course, usually 2-3 months

  10. Occurrence of air leak syndromes

    pneumothorax, pneumomediastinum confirmed on x ray

    Measured: During inpatient hospital course, usually 2-3 months

  11. Duration of assisted ventilation before discharge

    ventilation days on mechanical ventilator or continuous positive airway pressure (CPAP) respectively

    Measured: During inpatient hospital course, usually 2-3 months

  12. incidence of severe intraventricular hemorrhage (IVH)

    ultrasound finding of grade3-4 intraventricular hemorrhage

    Measured: During inpatient hospital course, usually 2-3 months

  13. incidence of necrotizing enterocolitis (NEC)

    diagnosis of NEC proven by abdominal X-rays, classified as Bell Stage II

    Measured: During inpatient hospital course, usually 2-3 months

  14. incidence of chronic lung disease (CLD)

    diagnosed when there is a need for oxygen at 36 weeks post menstrual age

    Measured: During inpatient hospital course, usually 2-3 months

  15. incidence of severe retinopathy of prematurity (ROP)

    diagnosed when there is a need for laser surgery for treatment of ROP

    Measured: During inpatient hospital course, usually 2-3 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Feb 2020
  2. Study start6 Jun 2019
  3. Primary completion10 Apr 2021
  4. Study completion30 Jun 2022

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
50 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04287907
Sponsor's protocol ID
2016/2405
Status last verified
Oct 2023
First submitted
19 Feb 2020
Last updated
4 Oct 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 19255015

  • 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.

    PubMed 16801392

  • 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.

    PubMed 27939108

  • 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.

    PubMed 38537615

Questions about this trial

What is this clinical trial studying?

A study testing Monitor Group in people with Preterm Birth, run by KK Women's and Children's Hospital at 1 site in Singapore.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 4 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Singapore. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Bradycardia and Desaturation Duration (time frame: This outcome will be obtained immediately after birth when available on pulse oximetry). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04287907, which also lists 4 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Oct 2023.

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