NCT04056091

Back Rubs or Foot Flicks for Neonatal Stimulation at Birth in a Low-resource Setting

Back Rubs or Foot Flicks for Neonatal Stimulation at Birth in a Low-resource Setting: an Open-label Randomised Superiority Trial

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 186 (estimated)
• Sponsor: University Hospital Padova · Academic / Other
• Sex: All
• Age: 1 Minute – 10 Minutes
• Healthy volunteers: Not accepted

Summary

Physical stimulation is the most common intervention during neonatal stabilization/resuscitation at birth and is recommended by neonatal resuscitation guidelines in high as well low-income settings. Two modalities of stimulation (back rubs or foot flicks) are recommended. This is a single center, unblinded, randomized superiority trial. Immediately after birth, all "not crying" infants will be randomly assigned in a 1:1 ratio to two different modes of stimulation (back rubs or foot flicks). Exclusion criteria will be stillbirths and presence of major neonatal malformations. The primary outcome measure will be the need for FMV. Secondary outcome measures will include Apgar score at 5 minutes, time of initiation and duration of FMV, time to first cry (defined as the first audible cry spontaneously emitted by the infant), death or moderate to severe hypoxic-ischemic encephalopathy within 7 days of life or at discharge, admission to special care, and procedure-associated complications. The results of the present study will help to identify the most appropriate mode for stimulating the apneic newly infants in delivery room. In clinical practice, this information is very relevant because effective stimulation at birth will elicit spontaneous respiratory in a certain percentage of apneic neonates avoiding the need for positive pressure ventilation and, possibly, further advanced resuscitative maneuvers.

Conditions

• Neonatal Resuscitation

Interventions

Type	Name	Description
PROCEDURE	Back rub stimulation	Immediately after birth, all infants with an expected birthweight \>1500 g who have been dried and remain apneic (not crying) will receive physical stimulation (back rubs). Stimulation can be repeated at maximum two or three times for about 3-5 seconds.
PROCEDURE	Foot flicks stimulation	Immediately after birth, all infants with an expected birthweight \>1500 g who have been dried and remain apneic (not crying) will receive physical stimulation (foot flicks). Stimulation can be repeated at maximum two or three times for about 3-5 seconds.

Timeline

• Start date: 2019-11-12
• Primary completion: 2020-06-30
• Completion: 2020-06-30
• First posted: 2019-08-14
• Last updated: 2020-04-06

Locations

1 site across 1 country: Uganda