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

Not Applicable

• Conditions: Neonatal Resuscitation

• Registration Number: NCT04056091
• Lead Sponsor: University Hospital Padova

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-08-07
• Study First Submitted QC: 2019-08-09
• Study First Posted: 2019-08-14
• Study Start: 2019-11-12
• Status Verified: 2020-04
• Last Update Submitted: 2020-04-02
• Last Update Posted: 2020-04-06
• Primary Completion: 2020-06-30
• Study Completion: 2020-06-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 186

Inclusion Criteria

1. Newly born infants who are apneic (not crying) immediately after birth (and)
2. Expected birthweight > 1500 g (and)
3. Parental consent

Exclusion Criteria

1. Still births
2. Twins
3. Major congenital malformations (i.e. congenital cardiac malformation, pulmonary hypoplasia, major spina bifida, etc.)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Percentage of babies needing positive pressure ventilation	2 minutes

Secondary Outcome Measures

Name	Time	Method
Peercentage of babies admitted to special care	2 hours
Time of duration of face-mask ventilation	20 minutes
Time to first cry	20 minutes
Percentage of deaths	7 days
Apgar score at 5 minutes	5 minutes	Apgar score is a scale from 0 (very bad) to 10 (very good) that classify the clinical condition of the neonates during the first minutes of life
Time of initiation of face-mask ventilation	5 minutes
Percentage of babies with moderate to severe hypoxic-ischemic encephalopathy	7 days	The grade of encephalopathy will be measured according to a modified Sarnat and Sarnat classification
Percentage of procedure-associated complications	3 days

Trial Locations

Locations (1)

Matany Hospital; 🇺🇬 Moroto, Karamoja, Uganda