Effects of Light Exposure for Postpartum Depression on Infant Development

NCT07440355 | Enrolling By Invitation

• 3 other identifiers: 2024-0089CAAE 78853224.5.0000.5327405657/2023-4
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

About 11% of women develop depression and anxiety after giving birth. These symptoms can reduce a mother's quality of life and daily functioning and may negatively affect her child's growth and development. Blue light therapy, based on chronobiology principles, has shown promising results for treating postpartum depression. It is relatively low-cost and has no known side effects. However, it is still unclear whether treating mothers with blue light therapy improves their children's growth and development. This study will investigate whether infants of mothers treated with blue light therapy for postpartum depression show better growth and developmental outcomes during their first year of life. Mothers diagnosed with postpartum depression within the first six weeks after childbirth will be assigned to one of two light exposure groups: a therapeutic blue light group or a control light exposure group (from another research study NCT06246214). A third group will include mothers without postpartum depression, and a fourth with previous depression. Children will be followed until 12 months of age. At that time, researchers will assess their growth, nutrition, and developmental milestones. The main goal is to compare child growth and development across these groups using statistical analyses.

Conditions

Development and Health; Nutrition

Keywords

child development; postpartum depression; light therapy; child growth

Outcome Measures

Primary Outcomes (8)

• Infant Development - Bayley

  The Bayley Scale of Infant and Toddler Development - 4th Edition (BSITD-4; Bayley, 2019). Bayley Scale is recognized as a gold-standard tool for assessing child development and identifying developmental delays across five domains: cognitive, language, motor, social-emotional, and adaptive behavior (Bayley \& Aylward, 2019). The cognitive, language, and motor domains involve structured activities administered to the child, with caregiver involvement as needed. The social-emotional and adaptive behavior domains are assessed via caregiver questionnaires. The BSITD-4 scoring is age-based, with a specific starting point for each domain. Raw scores are summed and scaled, and composite scores are calculated. Composite scores classify performance as: Very superior (\>130), superior (120-129), high average (110-119), average (90-109), low average (80-89), borderline (70-79), or extremely Low (\<69).

  At 1 to 1.5 months of age.

• Change from Baseline in Infant Development - Bayley

  The Bayley Scale of Infant and Toddler Development - 4th Edition (BSITD-4; Bayley, 2019). Bayley Scale is recognized as a gold-standard tool for assessing child development and identifying developmental delays across five domains: cognitive, language, motor, social-emotional, and adaptive behavior (Bayley \& Aylward, 2019). The cognitive, language, and motor domains involve structured activities administered to the child, with caregiver involvement as needed. The social-emotional and adaptive behavior domains are assessed via caregiver questionnaires. The BSITD-4 scoring is age-based, with a specific starting point for each domain. Raw scores are summed and scaled, and composite scores are calculated. Composite scores classify performance as: Very superior (\>130), superior (120-129), high average (110-119), average (90-109), low average (80-89), borderline (70-79), or extremely Low (\<69).

  At 6 months of age.

• Change from Baseline in Infant Development - Bayley

  The Bayley Scale of Infant and Toddler Development - 4th Edition (BSITD-4; Bayley, 2019). Bayley Scale is recognized as a gold-standard tool for assessing child development and identifying developmental delays across five domains: cognitive, language, motor, social-emotional, and adaptive behavior (Bayley \& Aylward, 2019). The cognitive, language, and motor domains involve structured activities administered to the child, with caregiver involvement as needed. The social-emotional and adaptive behavior domains are assessed via caregiver questionnaires. The BSITD-4 scoring is age-based, with a specific starting point for each domain. Raw scores are summed and scaled, and composite scores are calculated. Composite scores classify performance as: Very superior (\>130), superior (120-129), high average (110-119), average (90-109), low average (80-89), borderline (70-79), or extremely Low (\<69).

  At 12 months of age.

• Infant Development - DIACD

  The Dimensional Inventory for the Assessment of Child Development (DIACD; Silva et al., 2019, 2020), developed and validated for Brazilian children (de Mendonça et al., 2021; Miranda et al., 2020; Silva et al., 2020), is a multidimensional parental proxy report to identify potential developmental delays in children aged 4 to 72 months. The inventory is organized in seven domains: Cognitive, Socioemotional, Receptive Language and Communication, Expressive Language and Communication, Gross Motor, Fine Motor, and Adaptive Behavior. The DIACD takes about 30 minutes. Analyses examining evidence of reliability found values ranging from 0.97 to 0.99 for responses across domains. The standardized score has a mean of 100 and a standard deviation of 15. Children are classified as well above age expectations (\>130), above age expectations (123-130), typical development (85-116), risk of developmental delay (78-84), developmental delay (70-77), and significant developmental delay (\<70).

  At 6 months of age

• Change of Baseline in Infant Development - DIACD

  The Dimensional Inventory for the Assessment of Child Development (DIACD; Silva et al., 2019, 2020), developed and validated for Brazilian children (de Mendonça et al., 2021; Miranda et al., 2020; Silva et al., 2020), is a multidimensional parental proxy report to identify potential developmental delays in children aged 4 to 72 months. The inventory is organized in seven domains: Cognitive, Socioemotional, Receptive Language and Communication, Expressive Language and Communication, Gross Motor, Fine Motor, and Adaptive Behavior. The DIACD takes about 30 minutes. Analyses examining evidence of reliability found values ranging from 0.97 to 0.99 for responses across domains. The standardized score has a mean of 100 and a standard deviation of 15. Children are classified as well above age expectations (\>130), above age expectations (123-130), typical development (85-116), risk of developmental delay (78-84), developmental delay (70-77), and significant developmental delay (\<70).

  At 12 months of age.

• Anthropometric Measures of Infant Growth

  Infant weight, length, and head circumference, chest circumference, and body fat will be obtained by trained researchers during in-person visits, and the nutritional status will be calculated using the Anthro® software from the Brazilian Ministry of Health. Data will be collected in duplicate or triplicate by trained researchers using standardized protocols, with the average value recorded.

  At 1 to 1.5 months of age.

• Change from Baseline in Anthropometric Measures of Infant Growth

  Infant weight, length, and head circumference, chest circumference, and body fat will be obtained by trained researchers during in-person visits, and the nutritional status will be calculated using the Anthro® software from the Brazilian Ministry of Health. Data will be collected in duplicate or triplicate by trained researchers using standardized protocols, with the average value recorded.

  At 6 months of age.

• Change from Baseline in Anthropometric Measures of Infant Growth

  Infant weight, length, and head circumference, chest circumference, and body fat will be obtained by trained researchers during in-person visits, and the nutritional status will be calculated using the Anthro® software from the Brazilian Ministry of Health. Data will be collected in duplicate or triplicate by trained researchers using standardized protocols, with the average value recorded.

  At 12 months of age.

Secondary Outcomes (11)

• Breastfeeding Self-Efficacy - BSES

  At 1 to 1.5 months of age.

• Infant feeding practices - BEBQ

  At 6 months of age.

• Infant feeding practices - CEBQ

  At 12 months of age.

• Infant sleep problems - BISQ

  At 6 months of age.

• Change from Baseline in Infant sleep problems - BISQ

  At 12 months of age.

Other Outcomes (9)

• Infant development - Hammersmith Neonatal Neurological Examination

  At 1 to 1.5 months of age.

• Maternal dietary quality - SISVAN

  At 1 to 1.5 months of age.

• Change from Baseline in Maternal dietary quality - SISVAN

  At 4 months of age.

Study Arms (4)

Infants of PPD mothers treated with blue light therapy

Infants of mothers with postpartum depression symptoms who received blue light therapy at one month postpartum

Infants of PPD mothers treated with control light therapy

Infants of mothers with postpartum depression symptoms who received control light therapy at one month postpartum

Infants of mothers with no postpartum depression symptoms

Infants of mothers with no postpartum depression symptoms

Infants of depressive mothers

Infants of mothers with depression prior to birth

Eligibility Criteria

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

Study Population

Infants born to women 18 years or older, who speak fluent Portuguese and are 4 to 6 weeks postpartum, will participate.

You may qualify if:

• All eligible children born to mothers diagnosed with PPD up to six weeks postpartum and randomized into two light therapy groups (intervention and control), with an additional control group of mothers without a diagnosis of PPD. These mothers are being randomized in another study (Identifier NCT06246214 at ClinicalTrials.gov). Children born to mothers diagnosed with depression in the last year will enter the study as a fourth group.

You may not qualify if:

• Late preterm newborns (gestational age \< 33 weeks)
• Adverse peri- and neonatal outcomes:
• periventricular hemorrhage,
• leukomalacia,
• cardiorespiratory arrest,
• resuscitation,
• mechanical ventilation,
• genetic syndromes
• congenital malformations
• Vertical HIV exposure.

Sponsors & Collaborators

• Hospital de Clinicas de Porto Alegre: lead
• Federal University of Rio Grande do Sul: collaborator
• Conselho Nacional de Desenvolvimento Científico e Tecnológico: collaborator

Study Sites (1)

Hospital de Clínicas de Porto Alegre

Porto Alegre, Rio Grande do Sul, 90410-000, Brazil

Location

MeSH Terms

Conditions

Depression, Postpartum

Condition Hierarchy (Ancestors)

Puerperal Disorders; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Depressive Disorder; Mood Disorders; Mental Disorders

Study Officials

• Clécio H Silva, PhD

  Hospital de Clínicas de Porto Alegre

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 23, 2026
• First Posted: February 27, 2026
• Study Start: August 26, 2024
• Primary Completion (Estimated): December 20, 2027
• Study Completion (Estimated): August 30, 2028
• Last Updated: February 27, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)