NCT04056091

Brief 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
186

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Nov 2019

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 7, 2019

Completed
7 days until next milestone

First Posted

Study publicly available on registry

August 14, 2019

Completed
3 months until next milestone

Study Start

First participant enrolled

November 12, 2019

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2020

Completed
Last Updated

April 6, 2020

Status Verified

April 1, 2020

Enrollment Period

8 months

First QC Date

August 7, 2019

Last Update Submit

April 2, 2020

Conditions

Neonatal Resuscitation

Keywords

Neonatal resuscitationStimulationAsphyxia

Outcome Measures

Primary Outcomes (1)

  • Percentage of babies needing positive pressure ventilation

    2 minutes

Secondary Outcomes (8)

  • Apgar score at 5 minutes

    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

  • +3 more secondary outcomes

Study Arms (2)

Back rub stimulation

EXPERIMENTAL
Procedure: Back rub stimulation

Foot flicks stimulation

ACTIVE COMPARATOR
Procedure: Foot flicks stimulation

Interventions

Back rub stimulationPROCEDURE

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.

Back rub stimulation
Foot flicks stimulationPROCEDURE

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.

Foot flicks stimulation

Eligibility Criteria

Age1 Minute - 10 Minutes
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Newly born infants who are apneic (not crying) immediately after birth (and)
  • Expected birthweight \> 1500 g (and)
  • Parental consent

You may not qualify if:

  • Still births
  • Twins
  • Major congenital malformations (i.e. congenital cardiac malformation, pulmonary hypoplasia, major spina bifida, etc.)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Matany Hospital

Moroto, Karamoja, Uganda

RECRUITING

Related Publications (9)

  • 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.

    PMID: 28421171BACKGROUND

  • 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.

    PMID: 15036740RESULT

  • 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.

    PMID: 20483522RESULT

  • 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.

    PMID: 30236090RESULT

  • 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.

    PMID: 28600392RESULT

  • 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.

    PMID: 26477415RESULT

  • 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.

    PMID: 28419084RESULT

  • 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.

    PMID: 26473001RESULT

  • 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.

    PMID: 34438002DERIVED

Related Links

MeSH Terms

Conditions

Asphyxia

Condition Hierarchy (Ancestors)

DeathPathologic ProcessesPathological Conditions, Signs and SymptomsWounds and Injuries

Central Study Contacts

Daniele Trevisanuto, MD

CONTACT

+390498213545daniele.trevisanuto@unipd.it

Peter Lochoro, MD

CONTACT

+256312260097p.lochoro@cuamm.org

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Masking Details
Only statistician will be masked to tretament
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

August 7, 2019

First Posted

August 14, 2019

Study Start

November 12, 2019

Primary Completion

June 30, 2020

Study Completion

June 30, 2020

Last Updated

April 6, 2020

Record last verified: 2020-04

Data Sharing

IPD Sharing
Will not share

Locations

UG(1)