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Neonatal ResuscitationNCT04056091

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

A study testing Back rub stimulation and Foot flicks stimulation in people with Neonatal Resuscitation, run by University Hospital Padova at 1 site in Uganda.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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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. Read more about this study

Who is it for?
Ages 1 minute to 10 minutes
Conditions the study is for
Neonatal Resuscitation
What is being tested?
Back rub stimulation and Foot flicks stimulation
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
186 participants
Where
1 siteUganda
Study dates
12 Nov 2019to 30 Jun 2020
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 1 minute to 10 minutes
  • All sexes
  • No healthy volunteers
  • Child

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

Daniele Trevisanuto, MD contact

+390498213545

daniele.trevisanuto@unipd.it

Peter Lochoro, MD contact

+256312260097

p.lochoro@cuamm.org

Uganda1 site, 1 recruiting

  • Matany Hospital

    Moroto, Karamoja

    Daniele TREVISANUTO, IT-Italy, ++39 0498213545, daniele.trevisanuto@unipd.it

    Peter LOCHIRO, MD, ++256312260097, p.lochoro@cuamm.org

    Recruiting

Other trials in Uganda

About this study

Official title: 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.

Being tested
Back rub stimulation, Foot flicks stimulation
Keywords
Neonatal resuscitation, Stimulation, Asphyxia
Medical subject headings
Asphyxia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Back rub stimulationProcedure or surgery

    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 stimulationProcedure or surgery

    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.

Study groups in NCT04056091
Study groupRoleWhat they receive
Back rub stimulationExperimentalNot described
Receives: Procedure: Back rub stimulation
Foot flicks stimulationActive comparatorNot described
Receives: Procedure: Foot flicks stimulation

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Percentage of babies needing positive pressure ventilation

    Measured: 2 minutes

Secondary outcomes (8)

  1. 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

    Measured: 5 minutes

  2. Time of initiation of face-mask ventilation

    Measured: 5 minutes

  3. Time of duration of face-mask ventilation

    Measured: 20 minutes

  4. Time to first cry

    Measured: 20 minutes

  5. Percentage of deaths

    Measured: 7 days

  6. Peercentage of babies admitted to special care

    Measured: 2 hours

  7. Percentage of procedure-associated complications

    Measured: 3 days

  8. 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

    Measured: 7 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted14 Aug 2019
  2. Study start12 Nov 2019
  3. Primary completion30 Jun 2020 (estimated)
  4. Study completion30 Jun 2020 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
186 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04056091
Sponsor's protocol ID
MRRH-REC OUT0017/2019
Status last verified
Apr 2020
First submitted
7 Aug 2019
Last updated
6 Apr 2020
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

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.

    PubMed 28421171

  • 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.

    PubMed 15036740

  • 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.

    PubMed 20483522

  • 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.

    PubMed 30236090

  • 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.

    PubMed 28600392

  • 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.

    PubMed 26477415

  • 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.

    PubMed 28419084

  • 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.

    PubMed 26473001

  • 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.

    PubMed 34438002

Questions about this trial

What is this clinical trial studying?

A study testing Back rub stimulation and Foot flicks stimulation in people with Neonatal Resuscitation, run by University Hospital Padova at 1 site in Uganda.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 6 Apr 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Uganda. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Daniele Trevisanuto, MD (+390498213545, daniele.trevisanuto@unipd.it), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percentage of babies needing positive pressure ventilation (time frame: 2 minutes). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04056091, which also lists 9 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Apr 2020.

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