NCT02967562

Brief Summary

This study compares a fifteen second sustained inflation (SI) to five repeated two - three second 'inflation breaths' during resuscitation at delivery of infants born prematurely.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
63

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Nov 2016

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2016

Completed
14 days until next milestone

First Submitted

Initial submission to the registry

November 15, 2016

Completed
3 days until next milestone

First Posted

Study publicly available on registry

November 18, 2016

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2018

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2018

Completed
2.3 years until next milestone

Results Posted

Study results publicly available

November 10, 2020

Completed
Last Updated

November 10, 2020

Status Verified

March 1, 2018

Enrollment Period

1.3 years

First QC Date

November 15, 2016

Results QC Date

January 20, 2020

Last Update Submit

October 20, 2020

Conditions

Premature Birth

Outcome Measures

Primary Outcomes (1)

  • Expiratory Tidal Volume

    Expiratory tidal volume during the first minute of resuscitation

    one minute

Secondary Outcomes (1)

  • End Tidal Carbon Dioxide Level

    10 minutes

Other Outcomes (2)

  • Mechanical Ventilation

    48 hours

  • Adverse Effects

    First week of life

Study Arms (2)

Inflation Breaths

ACTIVE COMPARATOR

Five 'inflation breaths' lasting two - three seconds

Other: Inflation Breaths

Sustained inflation

EXPERIMENTAL

One fifteen second 'sustained inflation'

Other: Sustained Inflation

Interventions

Inflation BreathsOTHER
Inflation Breaths
Sustained InflationOTHER
Sustained inflation

Eligibility Criteria

Age0 Minutes - 1 Hour
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Infants born at less than 34 weeks gestation requiring resuscitation at delivery

You may not qualify if:

  • Major congenital abnormalities
  • Parents have previously expressed lack of consent for study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

King's College Hospital

London, Se5 9RS, United Kingdom

Location

Related Publications (1)

  • Hunt KA, Ali K, Dassios T, Milner AD, Greenough A. Sustained inflations versus UK standard inflations during initial resuscitation of prematurely born infants in the delivery room: a study protocol for a randomised controlled trial. Trials. 2017 Nov 28;18(1):569. doi: 10.1186/s13063-017-2311-y.

    PMID: 29179773DERIVED

MeSH Terms

Conditions

Premature Birth

Condition Hierarchy (Ancestors)

Obstetric Labor, PrematureObstetric Labor ComplicationsPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital Diseases

Results Point of Contact

Title
Professor Anne Greenough
Organization
King's College London
anne.greenough@kcl.ac.uk
02032999000

Study Officials

  • Anne Greenough, MD, FRCPCH

    King's College London

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 15, 2016

First Posted

November 18, 2016

Study Start

November 1, 2016

Primary Completion

March 1, 2018

Study Completion

August 1, 2018

Last Updated

November 10, 2020

Results First Posted

November 10, 2020

Record last verified: 2018-03

Locations

GB(1)