NCT05472155

Brief Summary

This study is designed to compare two different methods of oropharyngeal suctioning (with bulb syringe or suction catheter) in newborn infants at birth.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jul 2022

Shorter than P25 for not_applicable

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

First Submitted

Initial submission to the registry

July 21, 2022

Completed
Same day until next milestone

Study Start

First participant enrolled

July 21, 2022

Completed
4 days until next milestone

First Posted

Study publicly available on registry

July 25, 2022

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 30, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 30, 2022

Completed
Last Updated

December 5, 2023

Status Verified

December 1, 2023

Enrollment Period

3 months

First QC Date

July 21, 2022

Last Update Submit

December 2, 2023

Conditions

Neonatal Resuscitation

Outcome Measures

Primary Outcomes (1)

  • Oxygen saturation during the first 10 minutes of life

    Preductal oxygen saturation will be measured by a pulse-oxymeter during the first 10 minutes of life

    10 minutes

Secondary Outcomes (10)

  • Heart rate during the first 10 minutes of life

    10 minutes

  • Neonates with heart rate >100 beats per minute at 5 minutes

    5 minutes

  • Episodes of bradycardia in the first 10 minutes of life

    10 minutes

  • Neonates with saturation >80% at 5 minutes

    5 minutes

  • Time for achieving transcutaneous saturations >90%

    30 minutes

  • +5 more secondary outcomes

Study Arms (2)

Oropharyngeal suctioning with a bulb syringe

EXPERIMENTAL

Newborn infants who have obvious obstruction to spontaneous breathing or who require positive pressure ventilation immediately after birth will be suctioned with a bulb syringe

Device: Bulb syringe

Oropharyngeal suctioning with a suction catheter

ACTIVE COMPARATOR

Newborn infants who have obvious obstruction to spontaneous breathing or who require positive pressure ventilation immediately after birth will be suctioned with a suction catheter

Device: Suction catheter

Interventions

Bulb syringeDEVICE

Suctioning with a bulb syringe

Oropharyngeal suctioning with a bulb syringe
Suction catheterDEVICE

Suctioned with a suction catheter

Oropharyngeal suctioning with a suction catheter

Eligibility Criteria

Age1 Minute - 2 Days
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • inborn infants (and)
  • need for suctioning at birth (and)
  • parental consent

You may not qualify if:

  • Major congenital malformations
  • Parental refusal to participate in the study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

St. Luke Catholic Hospital, Wolisso, Ethiopia

Addis Ababa, Ethiopia

Location

Related Publications (4)

  • Patterson J, North K, Dempsey E, Ishoso D, Trevisanuto D, Lee AC, Kamath-Rayne BD; Newborn Brain Society Guidelines and Publications Committee. Optimizing initial neonatal resuscitation to reduce neonatal encephalopathy around the world. Semin Fetal Neonatal Med. 2021 Aug;26(4):101262. doi: 10.1016/j.siny.2021.101262. Epub 2021 Jun 22.

    PMID: 34193380RESULT

  • Foster JP, Dawson JA, Davis PG, Dahlen HG. Routine oro/nasopharyngeal suction versus no suction at birth. Cochrane Database Syst Rev. 2017 Apr 18;4(4):CD010332. doi: 10.1002/14651858.CD010332.pub2.

    PMID: 28419406RESULT

  • Lawn JE, Blencowe H, Oza S, You D, Lee AC, Waiswa P, Lalli M, Bhutta Z, Barros AJ, Christian P, Mathers C, Cousens SN; Lancet Every Newborn Study Group. Every Newborn: progress, priorities, and potential beyond survival. Lancet. 2014 Jul 12;384(9938):189-205. doi: 10.1016/S0140-6736(14)60496-7. Epub 2014 May 19.

    PMID: 24853593RESULT

  • Kamath-Rayne BD, Berkelhamer SK, Kc A, Ersdal HL, Niermeyer S. Neonatal resuscitation in global health settings: an examination of the past to prepare for the future. Pediatr Res. 2017 Aug;82(2):194-200. doi: 10.1038/pr.2017.48. Epub 2017 May 24.

    PMID: 28419084RESULT

Related Links

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Masking Details
Masking is not possible due to the study design. Only statistician who will perform the analysis will be blind to the arm allocation.
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

July 21, 2022

First Posted

July 25, 2022

Study Start

July 21, 2022

Primary Completion

October 30, 2022

Study Completion

October 30, 2022

Last Updated

December 5, 2023

Record last verified: 2023-12

Data Sharing

IPD Sharing
Will share

Data will be available upon reasonable request

Shared Documents
STUDY PROTOCOL, SAP, ICF

Locations

ET(1)