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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
186
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.
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.
Matany Hospital
Moroto, Karamoja, Uganda
RECRUITINGPercentage of babies needing positive pressure ventilation
Time frame: 2 minutes
Apgar score at 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 frame: 5 minutes
Time of initiation of face-mask ventilation
Time frame: 5 minutes
Time of duration of face-mask ventilation
Time frame: 20 minutes
Time to first cry
Time frame: 20 minutes
Percentage of deaths
Time frame: 7 days
Peercentage of babies admitted to special care
Time frame: 2 hours
Percentage of procedure-associated complications
Time frame: 3 days
Percentage of babies with moderate to severe hypoxic-ischemic encephalopathy
The grade of encephalopathy will be measured according to a modified Sarnat and Sarnat classification
Time frame: 7 days
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