Back Rubs or Foot Flicks for Neonatal Stimulation at Birth in a Low-resource Setting
NCT ID: NCT04056091
Last Updated: 2020-04-06
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
186 participants
INTERVENTIONAL
2019-11-12
2020-06-30
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Back rub stimulation
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
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.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
2. Expected birthweight \> 1500 g (and)
3. Parental consent
Exclusion Criteria
2. Twins
3. Major congenital malformations (i.e. congenital cardiac malformation, pulmonary hypoplasia, major spina bifida, etc.)
1 Minute
10 Minutes
ALL
No
Sponsors
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Jerry Ictho
UNKNOWN
John Bosco Nsubuga
UNKNOWN
Jesca Ameo
UNKNOWN
Giovanni Putoto
UNKNOWN
Peter Lochoro
UNKNOWN
University Hospital Padova
OTHER
Responsible Party
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Daniele Trevisanuto
Professor
Locations
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Matany Hospital
Moroto, Karamoja, Uganda
Countries
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Central Contacts
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Facility Contacts
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References
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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.
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.
Related Links
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Related Info
Related Info
Other Identifiers
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MRRH-REC OUT0017/2019
Identifier Type: -
Identifier Source: org_study_id
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