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NCT04665297
A Hybrid Effectiveness/Implementation Trial of the International Guide for Monitoring Child Development
NA trial testing International Guide for Monitoring Child Development in Child Development in 624 participants. Participants enrolled and being followed up; not accepting new ones.
30 April 2026
Quick facts
| Lead sponsor | Brigham and Women's Hospital |
|---|---|
| Phase | NA |
| Status | Active, enrolled |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | prevention |
| Enrollment | 624 |
| Start date | 17 January 2023 |
| Primary completion | 30 April 2026 |
| Estimated completion | 30 April 2026 |
| Sites | 2 locations across Guatemala, India |
Drugs / interventions tested
- International Guide for Monitoring Child Development
Conditions studied
- Child Development — all drugs for Child Development →
Sponsor
Brigham and Women's Hospital
Who can join
Adults 0 Months to 24 Months, any sex, with Child Development. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
The aim of this study is to conduct a hybrid effectiveness/implementation assessment of the International Guide for Monitoring Child Development (GMCD) in two LMIC settings, India and Guatemala, within established rural CHW programs. The primary objectives are (a) to evaluate the real-world effectiveness of the GMCD; (b) to use an implementation science framework to understand barriers and facilitators to effective population coverage, provider implementation, and maintenance; (c) to conduct an economic evaluation of the GMCD.
Publications & conference data
2 peer-reviewed publications reference this trial (live from Europe PMC):
-
Hybrid type 1 effectiveness/implementation trial of the international Guide for Monitoring Child Development: protocol for a cluster-randomised controlled trial.
Raut A, Mustafayev R, Srinivasan R, Chary A, et al · · 2021 · cited 4× · PMID 34604546 · DOI 10.1136/bmjpo-2021-001254 -
Methodology for adapting a co-created early childhood development intervention and implementation strategies for use by frontline workers in India and Guatemala: a systematic application of the FRAME-IS framework.
Bandal A, Hernández S, Mustafa R, Choy K, et al · · 2024 · PMID 38726569 · DOI 10.1080/16549716.2024.2338324
Verify or expand the search:
- PubMed search for NCT04665297
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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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 NCT04665297 (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 Brigham and Women's Hospital
- Last refreshed: 3 March 2026
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/NCT04665297.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing