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

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 Overview

• Status: Unknown
• Conditions: Neonatal Resuscitation
• Intervention / Treatment: Procedure: Back rub stimulation; Procedure: Foot flicks stimulation

• Study Type: Interventional
• Enrollment (Anticipated): 186
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Uganda
  • Karamoja
    • Moroto, Karamoja, Uganda
      • Recruiting
      • Matany Hospital
      • Contact: Daniele TREVISANUTO, IT-Italy; Phone Number: ++39 0498213545; Email: daniele.trevisanuto@unipd.it
      • Contact: Peter LOCHIRO, MD; Phone Number: ++256312260097; Email: p.lochoro@cuamm.org

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 minute to 10 minutes (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Back rub stimulation	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.
Active Comparator: Foot flicks stimulation	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: University Hospital Padova
• Collaborators: Jerry Ictho; John Bosco Nsubuga; Jesca Ameo; Giovanni Putoto; Peter Lochoro

Publications and helpful links

General Publications

• Dekker J, Martherus T, Cramer SJE, van Zanten HA, Hooper SB, Te Pas AB. Tactile Stimulation to Stimulate Spontaneous Breathing during Stabilization of Preterm Infants at Birth: A Retrospective Analysis. Front Pediatr. 2017 Apr 3;5:61. doi: 10.3389/fped.2017.00061. eCollection 2017.
• Owen CJ, Wyllie JP. Determination of heart rate in the baby at birth. Resuscitation. 2004 Feb;60(2):213-7. doi: 10.1016/j.resuscitation.2003.10.002.
• Voogdt KG, Morrison AC, Wood FE, van Elburg RM, Wyllie JP. A randomised, simulated study assessing auscultation of heart rate at birth. Resuscitation. 2010 Aug;81(8):1000-3. doi: 10.1016/j.resuscitation.2010.03.021. Epub 2010 May 18.
• Pietravalle A, Cavallin F, Opocher A, Madella S, Cavicchiolo ME, Pizzol D, Putoto G, Trevisanuto D. Neonatal tactile stimulation at birth in a low-resource setting. BMC Pediatr. 2018 Sep 20;18(1):306. doi: 10.1186/s12887-018-1279-4.
• Gaertner VD, Flemmer SA, Lorenz L, Davis PG, Kamlin COF. Physical stimulation of newborn infants in the delivery room. Arch Dis Child Fetal Neonatal Ed. 2018 Mar;103(2):F132-F136. doi: 10.1136/archdischild-2016-312311. Epub 2017 Jun 9. Erratum In: Arch Dis Child Fetal Neonatal Ed. 2021 Mar;106(2):e1.
• Wyllie J, Bruinenberg J, Roehr CC, Rudiger M, Trevisanuto D, Urlesberger B. European Resuscitation Council Guidelines for Resuscitation 2015: Section 7. Resuscitation and support of transition of babies at birth. Resuscitation. 2015 Oct;95:249-63. doi: 10.1016/j.resuscitation.2015.07.029. Epub 2015 Oct 15. No abstract available.
• Kamath-Rayne BD, Berkelhamer SK, Kc A, Ersdal HL, Niermeyer S. Neonatal resuscitation in global health settings: an examination of the past to prepare for the future. Pediatr Res. 2017 Aug;82(2):194-200. doi: 10.1038/pr.2017.48. Epub 2017 May 24.
• Wyckoff MH, Aziz K, Escobedo MB, Kapadia VS, Kattwinkel J, Perlman JM, Simon WM, Weiner GM, Zaichkin JG. Part 13: Neonatal Resuscitation: 2015 American Heart Association Guidelines Update for Cardiopulmonary Resuscitation and Emergency Cardiovascular Care. Circulation. 2015 Nov 3;132(18 Suppl 2):S543-60. doi: 10.1161/CIR.0000000000000267. No abstract available.
• Cavallin F, Lochoro P, Ictho J, Nsubuga JB, Ameo J, Putoto G, Trevisanuto D. Back rubs or foot flicks for neonatal stimulation at birth in a low-resource setting: A randomized controlled trial. Resuscitation. 2021 Oct;167:137-143. doi: 10.1016/j.resuscitation.2021.08.028. Epub 2021 Aug 23. Erratum In: Resuscitation. 2021 Oct 25;:

Helpful Links

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Study record dates

Study Major Dates

• Study Start (Actual): November 12, 2019
• Primary Completion (Anticipated): June 30, 2020
• Study Completion (Anticipated): June 30, 2020

Study Registration Dates

• First Submitted: August 7, 2019
• First Submitted That Met QC Criteria: August 9, 2019
• First Posted (Actual): August 14, 2019

Study Record Updates

• Last Update Posted (Actual): April 6, 2020
• Last Update Submitted That Met QC Criteria: April 2, 2020
• Last Verified: April 1, 2020

More Information

Terms related to this study

• Keywords: Asphyxia; Stimulation; Neonatal resuscitation
• Other Study ID Numbers: MRRH-REC OUT0017/2019

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No