Thai Baby Study Phase 1

NCT07498192 | Not Yet Recruiting

• 1 other identifier: 3399-1
• Study Type: observational
• Target: 10,300
• Locations: 0 countries
• Sites: N/A

Brief Summary

The goal of this observational study is to examine national trends in mode of delivery and to assess associations between cesarean section and early-life health outcomes using routinely collected health data in Thailand. The study includes mother-infant dyads delivering in public hospitals across Thailand. The main questions it aims to answer are: Is cesarean delivery associated with increased risk of adverse neonatal outcomes compared with vaginal delivery? Is cesarean delivery associated with differences in early-life healthcare utilization and breastfeeding outcomes during the first year of life? Researchers will compare infants born by cesarean section with infants born by vaginal delivery to evaluate differences in neonatal morbidity, healthcare utilization, and breastfeeding patterns. Participants will not receive any intervention. The study involves secondary analysis of de-identified national health administrative and clinical data, including delivery records and linked maternal and infant health outcomes.

Conditions

Outcome Assessment

Outcome Measures

Primary Outcomes (1)

• Neonatal health outcomes associated with mode of delivery

  Comparison of neonatal health outcomes, including birth asphyxia, neonatal infection, respiratory complications, and low birth weight, between infants born by cesarean section and vaginal delivery using routinely collected national health data.

  Birth to 28 days of life

Secondary Outcomes (3)

• Early-life healthcare utilization during infancy

  Birth to 12 months of age

• Breastfeeding outcomes by mode of delivery

  Birth to 12 months of age

• Temporal and geographic trends in cesarean delivery rates

  2015 to 2025

Study Arms (2)

Cesarean Delivery Cohort

Mother-infant dyads in which delivery occurred by cesarean section. This observational cohort is identified retrospectively using routinely collected, de-identified national health data. No intervention is assigned.

Vaginal Delivery Cohort

Mother-infant dyads in which delivery occurred by vaginal birth. This observational cohort is identified retrospectively using routinely collected, de-identified national health data. No intervention is assigned.

Eligibility Criteria

• Age: Up to 120 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

This study includes mother-infant dyads identified retrospectively from routinely collected, de-identified national health administrative and clinical data from public hospitals in Thailand.

You may qualify if:

• Mother-infant dyads with delivery records available in the national health administrative database.
• Deliveries occurring in public hospitals in Thailand during the study period.
• Records containing information on mode of delivery and linked maternal and infant outcomes.

You may not qualify if:

• Records with missing or invalid delivery mode information.
• Records that cannot be reliably linked between mother and infant.

Sponsors & Collaborators

• Mead Johnson Nutrition: lead
• Chulalongkorn University: collaborator
• Ministry of Health, Thailand: collaborator

Study Officials

• Veronica Fabrizio, DO

  Mead Johnson Nutrition

  STUDY DIRECTOR

• Krit Pongpirul, MD, MPH, PhD

  Chulalongkorn University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jami Walker, MSc

CONTACT

812-429-7299; jami.walker@reckitt.com

Amber Jessell

CONTACT

812-429-8903; amber.jessell@reckitt.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 23, 2026
• First Posted: March 27, 2026
• Study Start: March 1, 2026
• Primary Completion: May 30, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: March 27, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share