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

Neonatal Resuscitation Clinical Trial

— NEOSUC  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05472155
• Other study ID #: NEOUNIPD3(2022)
• Status: Completed
• Phase: N/A
• Start date: July 21, 2022
• Est. completion date: October 30, 2022

Study information

• Verified date: December 2023
• Source: University Hospital Padova
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: October 30, 2022
• Est. primary completion date: October 30, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 1 Minute to 2 Days

Eligibility

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

Related Conditions & MeSH terms

• Neonatal Resuscitation

Intervention

Device:
• Bulb syringe
Suctioning with a bulb syringe
• Suction catheter
Suctioned with a suction catheter

Locations

Country	Name	City	State
Ethiopia	St. Luke Catholic Hospital, Wolisso, Ethiopia	Addis Ababa

Sponsors (2)

Lead Sponsor	Collaborator
University Hospital Padova	Doctors with Africa - CUAMM

Country where clinical trial is conducted

Ethiopia, 

References & Publications (4)

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. — View Citation

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. — View Citation

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- — View Citation

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 Neona — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	Neonates with saturation >80% at 5 minutes	Number (percentage) of neonates with saturation >80% at 5 minutes	5 minutes
Secondary	Time for achieving transcutaneous saturations >90%	Time needed for achieving transcutaneous saturations >90 from birth	30 minutes
Secondary	Face-mask ventilation	Number (percentage) of infants who need for face-mask ventilation according to the neonatal algorithm	10 minutes
Secondary	Supplemental oxygen in delivery room	Number (percentage) of infants who needed supplemental oxygen in delivery room	30 minutes
Secondary	Admission to the special care unit	Number (percentage) of infants who were admitted to the special care unit	30 minutes
Secondary	Local lesions	Number (percentage) of local lesions (defined as bleeding from the mouth and/or the nose) due to suctioning procedure	10 minutes
Secondary	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

External Links

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