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

Neonatal Resuscitation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04056091
• Other study ID #: MRRH-REC OUT0017/2019
• Status: Recruiting
• Phase: N/A
• Start date: November 12, 2019
• Est. completion date: June 30, 2020

Study information

• Verified date: April 2020
• Source: University Hospital Padova
• Contact: Daniele Trevisanuto, MD
• Phone: +390498213545
• Email: daniele.trevisanuto[@]unipd.it
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 186
• Est. completion date: June 30, 2020
• Est. primary completion date: June 30, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 10 Minutes

Eligibility

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.)

Related Conditions & MeSH terms

• Neonatal Resuscitation

Intervention

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.
• 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.

Locations

Country	Name	City	State
Uganda	Matany Hospital	Moroto	Karamoja

Sponsors (6)

Lead Sponsor	Collaborator
University Hospital Padova	Giovanni Putoto, Jerry Ictho, Jesca Ameo, John Bosco Nsubuga, Peter Lochoro

Country where clinical trial is conducted

Uganda, 

References & Publications (8)

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. — View Citation

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. — View Citation

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. Review. — View Citation

Owen CJ, Wyllie JP. Determination of heart rate in the baby at birth. Resuscitation. 2004 Feb;60(2):213-7. — View Citation

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. — View Citation

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. — View Citation

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 — View Citation

Wyllie J, Bruinenberg J, Roehr CC, Rüdiger 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 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of babies needing positive pressure ventilation		2 minutes
Secondary	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
Secondary	Time of initiation of face-mask ventilation		5 minutes
Secondary	Time of duration of face-mask ventilation		20 minutes
Secondary	Time to first cry		20 minutes
Secondary	Percentage of deaths		7 days
Secondary	Peercentage of babies admitted to special care		2 hours
Secondary	Percentage of procedure-associated complications		3 days
Secondary	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

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