NCT04665297 - Clinical Trial References

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Citation(s)

Ertem IO, Dogan DG, Gok CG, Kizilates SU, Caliskan A, Atay G, Vatandas N, Karaaslan T, Baskan SG, Cicchetti DV
A guide for monitoring child development in low- and middle-income countries. Pediatrics. 2008 Mar;121(3):e581-9. doi: 10.1542/peds.2007-1771.
Ertem IO, Krishnamurthy V, Mulaudzi MC, Sguassero Y, Balta H, Gulumser O, Bilik B, Srinivasan R, Johnson B, Gan G, Calvocoressi L, Shabanova V, Forsyth BWC
Similarities and differences in child development from birth to age 3 years by sex and across four countries: a cross-sectional, observational study. Lancet Glob Health. 2018 Mar;6(3):e279-e291. doi: 10.1016/S2214-109X(18)30003-2.

An Individualized Approach to Promote Nurturing Care in Low and Middle Income Countries: A Hybrid Effectiveness/Implementation Trial of the International Guide for Monitoring Child Development

Details for clinical trial NCT04665297

Clinical trial NCT04665297 - References