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NCT04056091
Back Rubs or Foot Flicks for Neonatal Stimulation at Birth in a Low-resource Setting
NA trial testing Back rub stimulation in Neonatal Resuscitation in 186 participants. Status unknown.
30 June 2020
Quick facts
| Lead sponsor | University Hospital Padova |
|---|---|
| Phase | NA |
| Status | Status unknown |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 186 |
| Start date | 12 November 2019 |
| Primary completion | 30 June 2020 |
| Estimated completion | 30 June 2020 |
| Sites | 1 location across Uganda |
Drugs / interventions tested
- Back rub stimulation
- Foot flicks stimulation
Conditions studied
- Neonatal Resuscitation — all drugs for Neonatal Resuscitation →
Sponsor
University Hospital Padova
Who can join
Adults 1 Minute to 10 Minutes, any sex, with Neonatal Resuscitation. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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.
Publications & conference data
1 peer-reviewed publication reference this trial (live from Europe PMC):
-
Back rubs or foot flicks for neonatal stimulation at birth in a low-resource setting: A randomized controlled trial.
Cavallin F, Lochoro P, Ictho J, Nsubuga JB, et al · · 2021 · cited 7× · PMID 34438002 · DOI 10.1016/j.resuscitation.2021.08.028
Verify or expand the search:
- PubMed search for NCT04056091
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
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Other University Hospital Padova trials
Trials by the same sponsor.
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT04056091 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by University Hospital Padova
- Last refreshed: 6 April 2020
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04056091.
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