Clinical trial NCT05472155: SUCTIONING AT BIRTH WITH BULB SYRINGE OR SUCTION CATHETER: A RANDOMIZED CONTROLLED TRIAL
Official title: SUCTIONING AT BIRTH WITH BULB SYRINGE OR SUCTION CATHETER: A RANDOMIZED CONTROLLED TRIAL
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Neonatal Resuscitation
Lead sponsor: University Hospital Padova
Sponsor class: OTHER
Collaborators: name: Doctors with Africa - CUAMM
First posted: 2022-07-25
Enrollment: 60
Sex: ALL
Minimum age (years): 1
Maximum age (years): 2
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Oxygen saturation during the first 10 minutes of life
timeFrame: 10 minutes
Secondary outcomes:
measure: Heart rate during the first 10 minutes of life
timeFrame: 10 minutes
measure: Neonates with heart rate >100 beats per minute at 5 minutes
timeFrame: 5 minutes
measure: Episodes of bradycardia in the first 10 minutes of life
timeFrame: 10 minutes
measure: Neonates with saturation >80% at 5 minutes
timeFrame: 5 minutes
measure: Time for achieving transcutaneous saturations >90%
timeFrame: 30 minutes
measure: Face-mask ventilation
timeFrame: 10 minutes
measure: Supplemental oxygen in delivery room
timeFrame: 30 minutes
measure: Admission to the special care unit
timeFrame: 30 minutes
measure: Local lesions
timeFrame: 10 minutes
measure: Respiratory distress during the first 48 hours of life
timeFrame: 48 hours
Other outcomes:
Locations:
city: Addis Ababa
country: Ethiopia
facility: St. Luke Catholic Hospital, Wolisso, Ethiopia
Study officials:
References:
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 Neonatal Med. 2021 Aug;26(4):101262. doi: 10.1016/j.siny.2021.101262. Epub 2021 Jun 22.
citation: 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.
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):189-205. doi: 10.1016/S0140-6736(14)60496-7. Epub 2014 May 19.
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.