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An Observational Study to Characterize Human Milk From Mothers Delivering Term SGA and AGA Infants.

NCT02421445 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 142

Last updated 2019-04-24

No results posted yet for this study

Summary

This is an observational study to characterize human milk of mothers delivering term SGA and term AGA infants. This is an observational, exploratory, longitudinal (from birth to 6 months postpartum), 4 parallel groups, and multi-centric study. Total 300 subjects will be randomised in the study assuming 20% dropout, 240 subjects will be enrolled. The recruitment period for the study in India is for 6 months.

Conditions

  • Small for Gestational Age (SGA) Infants
  • Appropriate for Gestational Age (AGA) Infants

Sponsors & Collaborators

  • Société des Produits Nestlé (SPN)

    lead INDUSTRY

Principal Investigators

  • Neelam Kler, Dr · Sir Ganga Ram Hospital, Delhi

  • Anil Kumar Sapare, DR · Muzumdar Shaw Medical Centre, Bengalore

  • Sarika Prasad, Dr · Aadithya Adhikari Hospital

Eligibility

Min Age
18 Years
Max Age
40 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2015-04-30
Primary Completion
2018-06-30
Completion
2018-12-30

Countries

  • India

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02421445 on ClinicalTrials.gov