NCT07758283

Brief Summary

The iRRRd study is an ongoing prospective longitudinal prenatal birth cohort study based in Cox's Bazar, Bangladesh. Between February 2023 and March 2024, 2,888 pregnant women were enrolled (approximately 80% Rohingya refugees living in camps, 20% Bangladeshi host community). The study aims to investigate (1) the effects of being conceived, gestated, born, and raised in contexts of conflict and forced displacement on child health and development; (2) the mechanisms underlying the intergenerational transmission of conflict and displacement trauma to offspring; and (3) the sources of heterogeneity in these associations across individual, social, biological, and contextual risk and protective factors. Five waves of data collection have been completed: prenatal recruitment (Wave 1), third-trimester follow-up for a subset of the sample (Wave 2), birth (Wave 3), 28 days postpartum (Wave 4), and 6 months postpartum (Wave 5, completed April 2025; N=2,526). This registration covers Wave 6, the 36-month follow-up, in which target children are assessed when they reach 36 months of age. Anticipated enrollment for this wave is approximately 2,200 mother-child dyads. Waves 1-5 were conducted without preregistration due to logistical and timing constraints inherent to launching large-scale research in a complex humanitarian context. Design and preparation for the 36-month wave began in June-July 2025, and field piloting of study procedures and measures began in September 2025. Follow-ups with children reaching 36 months of age began in late May 2026. The original planning estimate of March 2026 reflected the 36-month mark for the earliest-born children in the cohort (first births occurred in March 2023); the ±2-month eligibility window (Part 5) accommodated the modest delay to actual fieldwork start. Up to the first week of August, fieldwork progressed slowly with a smaller number of enumerators, as several measures were still being refined and modified based on ongoing piloting. We consider this wave officially launched once onboarding and training of an expanded group of data collectors is complete and the pace of follow-ups picks up with number of children turning 36 months of age. All field activities that predate this registration are considered piloting and have served to iron out remaining logistical, technical, and language issues, and to finalize decisions on tool and item selection. No data have been analyzed, with the exception of measures for which psychometric properties needed to be examined to inform modification and selection decisions.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
2,200

participants targeted

Target at P75+ for all trials

Timeline
13mo left

Started May 2026

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress19%
May 2026Sep 2027

Study Start

First participant enrolled

May 15, 2026

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

August 6, 2026

Completed
5 days until next milestone

First Posted

Study publicly available on registry

August 11, 2026

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2027

Last Updated

August 11, 2026

Status Verified

August 1, 2026

Enrollment Period

1.3 years

First QC Date

August 6, 2026

Last Update Submit

August 6, 2026

Conditions

Keywords

Rohingyarefugeebirth cohortlongitudinalprenatalBangladeshexecutive functionBayleyearly childhoodplayplayful learningparentingbiomarkerssalivaepigeneticsheart rate variabilityadversityresilienceLMIC

Outcome Measures

Primary Outcomes (2)

  • Cognitive Development

    Instrument: Bayley Scales of Infant and Toddler Development, Fourth Edition (Bayley-IV) - Cognitive subscale; directly administered

    1st of 3 visits at 36 months of age

  • Executive Function

    Directly administered tasks adapted for cultural and contextual appropriateness with Rohingya and host community children. Assessment of inhibitory control \& cognitive flexibility (Fruit Stroop), Attention Control ("Walking on line / oval holding bell"), working memory (Tracking Hidden Object).

    Visit 1 of the 36-month follow-up

Secondary Outcomes (4)

  • Child physical growth and nutritional status

    Visit 3 of 36-month follow-up

  • Child prosocial behavior

    Visit 3 of 36-month follow-up

  • Child autonomic nervous system functioning - parasympathetic

    Visit 3 of 36-month follow-up

  • Child behavioral problems (caregiver report)

    Visit 2 of 36-month follow-up

Eligibility Criteria

Age36 Months - 38 Months
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)
Sampling MethodNon-Probability Sample
Study Population

The prenatal cohort consists of 2,322 Rohingya women recruited from 8 camps in the Kutupalong camp cluster and 566 women from surrounding host communities in Cox's Bazar, Bangladesh. Rohingya participants, a stateless minority from Rakhine, Myanmar, who fled persecution and violence primarily in 2017-2018. The host community is composed of Bangladeshi nationals from Chittagonian-speaking communities adjacent to the camps. At prenatal recruitment, approximately 68% of Rohingya women were unable to read in any language; mean age was 21.2 years, with approximately 41% under 19 years of age. Consent is obtained verbally - due to high rates of illiteracy - in Rohingya/Chittagonian or Bangla, by female enumerators for female participants and male enumerators for male participants.

You may qualify if:

  • Mother/primary female caregiver was enrolled in the iRRRd prenatal cohort (recruited February 2023 - March 2024 when pregnant)
  • Target child is alive and 36 months of age (+/- 2 months)
  • Household can be located and reached within the study area
  • Caregiver provides informed consent for continued participation

You may not qualify if:

  • Target child has died prior to the 36-month visit
  • Household has permanently migrated out of the study area and cannot be located
  • Caregiver is in severe acute distress and unable to participate safely
  • Caregiver refuses continued participation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Rohingya camps, host communities

Ukhiya, Cox's Bazar, 4750, Bangladesh

Location

Related Publications (7)

  • Ahamed S, Ugarte E, Elahi M, Hossain E, Rahman S, Sanin KI, Dutta A, Dutta GK, Wuermli AJ, Tofail F. Association Between Birth Outcomes and Gestational Weight Gain Among Forcibly Displaced Rohingya and Nearby Host Community, in Cox's Bazar, Bangladesh. Life (Basel). 2025 Nov 19;15(11):1773. doi: 10.3390/life15111773.

  • Elahi M, Sanin KI, Rahman MS, Hiott C, Ugarte E, Ahamed MS, Hossain MM, Hossian E, Mitu SRI, Akhter RM, Roy BR, Dutta GK, Wuermli AJ, Tofail F. Association between mental health and sleep quality among Forcibly Displaced Rohingya pregnant women living in Cox's Bazar, Bangladesh: a cross-sectional observation. BMC Psychiatry. 2026 Jan 16;26(1):103. doi: 10.1186/s12888-025-07561-1.

  • Simon D, Michael D, Rahman MS, Hiott MC, Rahim AK, Sanin KI, Tofail F, Wuermli AJ. Predictors of antenatal care utilization among the Rohingya population in the refugee camps of Cox's Bazar, Bangladesh. Confl Health. 2025 Dec 3;20(1):1. doi: 10.1186/s13031-025-00733-6.

  • Trang K, Hiott C, Rahim AK, Rahman S, Wuermli AJ. A qualitative study of cultural concepts of distress among Rohingya refugees in Cox's Bazar, Bangladesh. Confl Health. 2024 Jul 30;18(1):48. doi: 10.1186/s13031-024-00606-4.

  • Ugarte E, Hastings PD, Hossain E, Ahamed MS, Rahim AK, Elahi M, Rahman MS, Tofail F, Wuermli AJ. A Protocol to Acquire Infant Heart Rate Variability in the Rohingya Camps and Surrounding Communities in Cox's Bazar, Bangladesh. Psychophysiology. 2026 Aug;63(8):e70356. doi: 10.1111/psyp.70356.

  • Ugarte E, Hiott MC, Elahi M, Hossain E, Ahamed MS, Rahman MS, Tofail F, Hastings PD, Wuermli AJ. Maternal Mental Health and Infant Parasympathetic Activity in the Context of Forced Displacement: Insights From the Rohingya Camps and Surrounding Communities in Cox's Bazar, Bangladesh. Dev Psychobiol. 2025 Nov;67(6):e70102. doi: 10.1002/dev.70102.

  • Wuermli A, Hiott MC, Ugarte E, Rahman MS, Elahi M, Rahim AK, Dutta GK, Ahamed MS, Roy BR, Akhter RM, Hossain E, Michael D, Ayrin TK, Haseen SH, Alam RB, Ratul TI, Horaira MA, Gladstone M, Sanin KI, Raqib R, Hamadani J, Yoshikawa H, Hastings PD, Tofail F. Cohort profile: a prenatal birth cohort study of intergenerational risk and resilience after conflict and forced displacement. BMJ Open. 2025 Nov 4;15(11):e099052. doi: 10.1136/bmjopen-2025-099052.

Related Links

Biospecimen

Retention: SAMPLES WITH DNA

The study maintains a biobank of saliva samples collected at each wave from mothers (pregnancy through 6 months) and children (1 month through current 36 months), and buccal swab specimens collected from all mothers and fathers (and siblings aged 3-5 where present) at recruitment (prenatal wave) and from all infants at 1 month. Saliva from a subsample of 350 mother-infant dyads has already undergone untargeted proteomics and untargeted and targeted metabolomics (mother sample during pregnancy and infant sample at 1 month). All remaining specimens are banked and awaiting assay.

MeSH Terms

Conditions

Psychological Well-BeingCombat DisordersHistorical Trauma

Condition Hierarchy (Ancestors)

Personal SatisfactionBehaviorStress Disorders, TraumaticTrauma and Stressor Related DisordersMental DisordersPsychological Trauma

Study Officials

  • Alice J Wuermli, PhD

    New York University

    PRINCIPAL INVESTIGATOR
  • Fahmida Tofail, PhD

    international center for diarrheal disease research, Bangladesh

    PRINCIPAL INVESTIGATOR
  • Paul Hastings, PhD

    University of California, Davis

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Research Assistant Professor

Study Record Dates

First Submitted

August 6, 2026

First Posted

August 11, 2026

Study Start

May 15, 2026

Primary Completion (Estimated)

September 1, 2027

Study Completion (Estimated)

September 1, 2027

Last Updated

August 11, 2026

Record last verified: 2026-08

Locations