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

University Hospital Padova

Status: Unknown

Conditions: Neonatal Resuscitation

Treatments: Procedure: Foot flicks stimulation; Procedure: Back rub stimulation

Study type: Interventional

Funder types: Other

Identifiers

NCT04056091

MRRH-REC OUT0017/2019

Details and patient eligibility

About

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.

Enrollment: 186 estimated patients

Sex: All

Ages: 1 to 10 minutes old

Volunteers: No Healthy Volunteers

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.)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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186 participants in 2 patient groups

Back rub stimulation

Experimental group

Treatment:

Procedure: Back rub stimulation

Foot flicks stimulation

Active Comparator group

Treatment:

Procedure: Foot flicks stimulation