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

Study Overview
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Brief Summary
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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.

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

Conditions
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Neonatal Resuscitation

Intervention / Treatment
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* Procedure: Back rub stimulation
* Procedure: Foot flicks stimulation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Newly born infants who are apneic (not crying) immediately after birth (and) Expected birthweight > 1500 g (and) Parental consent Exclusion Criteria: Still births Twins Major congenital malformations (i.e. congenital cardiac malformation, pulmonary hypoplasia, major spina bifida, etc.)

Ages Eligible for Study
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Minimum Age: 1 Minute
Maximum Age: 10 Minutes

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Back rub stimulation<br> | Procedure: Back rub stimulation<br>* 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.<br>|
| Active Comparator: Foot flicks stimulation<br> | Procedure: Foot flicks stimulation<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of babies needing positive pressure ventilation |  | 2 minutes | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 5 minutes | 
| Time of initiation of face-mask ventilation |  | 5 minutes | 
| Time of duration of face-mask ventilation |  | 20 minutes | 
| Time to first cry |  | 20 minutes | 
| Percentage of deaths |  | 7 days | 
| Peercentage of babies admitted to special care |  | 2 hours | 
| Percentage of procedure-associated complications |  | 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 | 7 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Neonatal resuscitation, Stimulation, Asphyxia