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NCT03141723
Kangaroo Mother Care With Plastic Bag (Trials 2A & 2B)
NA trial testing KMC & WHO protocol (0-1 hour) in Preterm Infant in 423 participants. Completed in 12 August 2017.
12 August 2017
Quick facts
| Lead sponsor | University of Alabama at Birmingham |
|---|---|
| Phase | NA |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | prevention |
| Enrollment | 423 |
| Start date | 19 May 2017 |
| Primary completion | 12 August 2017 |
| Estimated completion | 12 August 2017 |
| Sites | 1 location across Zambia |
Drugs / interventions tested
- KMC & WHO protocol (0-1 hour)
- KMC, WHO protocol & bag (0-1 hour)
- KMC & WHO protocol (1-24 hours)
- KMC, WHO protocol & bag (1-24 hours)
Conditions studied
- Preterm Infant — all drugs for Preterm Infant →
- Hypothermia Neonatal — all drugs for Hypothermia Neonatal →
Sponsor
University of Alabama at Birmingham
Who can join
Adults 10 Minutes to 24 Hours, any sex, with Preterm Infant or Hypothermia Neonatal. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
The purpose of this study is to determine whether the combination of Kangaroo Mother Care (KMC) as continuously as possible together with the use of a plastic bag in combination with routine World Health Organization (WHO) thermoregulation care reduces the incidence of moderate (32-36° C) or severe (\<32.0° C) hypothermia in term infants ≥ 37 0/7 weeks of gestational age (GA) when compared to KMC as continuously as possible together with routine WHO thermoregulation care.
Publications & conference data
1 peer-reviewed publication reference this trial (live from Europe PMC):
-
Early Skin-to-Skin Care with a Polyethylene Bag for Neonatal Hypothermia: A Randomized Clinical Trial.
Travers CP, Ramani M, Gentle SJ, Schuyler A, et al · · 2021 · cited 9× · PMID 33373672 · DOI 10.1016/j.jpeds.2020.12.064
Verify or expand the search:
- PubMed search for NCT03141723
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of KMC & WHO protocol (0-1 hour)
Trials testing the same drug.
- NCT03141736 — Kangaroo Mother Care With Plastic Bag (Trials 1A & 1B) · NA · withdrawn
Other recruiting trials for Preterm Infant
Currently open trials in the same condition.
- NCT06786039 — Clinical Impact of Non-invasive Neurally Adjusted Ventilatory Assist in Very Preterm Infants · recruiting
- NCT06532695 — Development, ADL, Participation, and Quality of Life in Preterm Infants: Longitudinal Research · recruiting
- NCT07238231 — Taiwan Preterm Infant Database: Analysis and Comparison of Birth Conditions and Exploration of Prognostic Factors · active not recruiting
- NCT03518736 — Does Timing Matter? Supporting Play, Exploration, and Early Developmental Intervention · NA · active not recruiting
- NCT03373721 — Gut Microbiota of Preterm Infants and Full-term Infants at Early Life · recruiting
Other University of Alabama at Birmingham trials
Trials by the same sponsor.
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- NCT05060380 — Feasibility of a Novel Resistance Exercise in Individuals With Osteoporosis · NA · withdrawn
- NCT04768777 — Behavioral Intervention for Physical Activity and Sexual Dysfunction in Multiple Sclerosis · NA · not yet recruiting
- NCT06320951 — VITAL-IMPACT: Improving Cardiometabolic Health in Black Individuals Through Therapeutic Augmentation of Cyclic Guanosine · Phase 2 · not yet recruiting
- NCT07564934 — Leveraging Extended Reality Exergaming and Telehealth to Improve Physical Activity and Health in Children With Disabilit · Phase 2 · not yet recruiting
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 NCT03141723 (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 of Alabama at Birmingham
- Last refreshed: 18 June 2018
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/NCT03141723.
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