SUCTIONING AT BIRTH WITH BULB SYRINGE OR SUCTION CATHETER: A RANDOMIZED CONTROLLED TRIAL (NEOSUC)

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

Study Overview

• Status: Completed
• Conditions: Neonatal Resuscitation
• Intervention / Treatment: Device: Bulb syringe; Device: Suction catheter

Detailed Description

Objective of the study: This trial aims to compare two different methods of oropharyngeal suctioning (with bulb syringe or suction catheter) in newborn infants needing suctioning at birth.

Primary outcome measure: Oxygen saturation during the first 10 minutes of life.

Study design: This is a single center, prospective, randomized clinical trial comparing two different methods of oropharyngeal suctioning (with bulb syringe or suction catheter) in newborn infants needing suctioning at birth.

Setting: The study is conducted at the St. Luke Catholic Hospital in Wolisso (Ethiopia), which is a level III hospital with around 3,600 deliveries per year.

Immediately after birth, all infants needing suctioning are randomized to receive suctioning with bulb syringe or suction catheter. All resuscitative procedures are performed following the Helping Babies Breathe algorithm. An external observer, not involved in the care of the newborn, is responsible of the positioning the probe of the pulse oximeter and the collection of the data.

We aim to enroll 60 neonates.

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Ethiopia
  • Addis Ababa, Ethiopia
    • St. Luke Catholic Hospital, Wolisso, Ethiopia

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 minute to 2 days (Child)
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Oropharyngeal suctioning with a bulb syringe; 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; Suctioning with a bulb syringe
Active Comparator: Oropharyngeal suctioning with a suction catheter; 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; Suctioned with a suction catheter

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Heart rate during the first 10 minutes of life	Heart rate will be monitored by a pulse-oxymeter during the first 10 minutes of life	10 minutes
Neonates with heart rate >100 beats per minute at 5 minutes	Number (percentage) of neonates with heart rate >100 bpm at 5 minutes	5 minutes
Episodes of bradycardia in the first 10 minutes of life	Episodes of bradycardia will be defined as heart rate <100 beats per minute in the first 10 minutes of life	10 minutes
Neonates with saturation >80% at 5 minutes	Number (percentage) of neonates with saturation >80% at 5 minutes	5 minutes
Time for achieving transcutaneous saturations >90%	Time needed for achieving transcutaneous saturations >90 from birth	30 minutes
Face-mask ventilation	Number (percentage) of infants who need for face-mask ventilation according to the neonatal algorithm	10 minutes
Supplemental oxygen in delivery room	Number (percentage) of infants who needed supplemental oxygen in delivery room	30 minutes
Admission to the special care unit	Number (percentage) of infants who were admitted to the special care unit	30 minutes
Local lesions	Number (percentage) of local lesions (defined as bleeding from the mouth and/or the nose) due to suctioning procedure	10 minutes
Respiratory distress during the first 48 hours of life	Number (percentage) of infants with respiratory distress (defined as need for supplemental oxygen and/or nasal-CPAP) during the first 48 hours of life	48 hours

Collaborators and Investigators

• Sponsor: University Hospital Padova
• Collaborators: Doctors with Africa - CUAMM

Publications and helpful links

General Publications

• 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.
• 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.
• 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.
• 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. Erratum In: Lancet. 2014 Jul 12;384(9938):132.

Helpful Links

• Related Info

Study record dates

Study Major Dates

• Study Start (Actual): July 21, 2022
• Primary Completion (Actual): October 30, 2022
• Study Completion (Actual): October 30, 2022

Study Registration Dates

• First Submitted: July 21, 2022
• First Submitted That Met QC Criteria: July 21, 2022
• First Posted (Actual): July 25, 2022

Study Record Updates

• Last Update Posted (Actual): December 5, 2023
• Last Update Submitted That Met QC Criteria: December 2, 2023
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Other Study ID Numbers: NEOUNIPD3(2022)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Data will be available upon reasonable request
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No