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.
Eligibility
Sex
ALL
Min age
—
Max age
—
Healthy volunteers
Accepted
Inclusion Criteria:
* 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.
Exclusion Criteria:
* 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.
Primary outcome measure(s)
Infant Development - Bayley — At 1 to 1.5 months of age. 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).
Change from Baseline in Infant Development - Bayley — At 6 months of age. 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).
Change from Baseline in Infant Development - Bayley — At 12 months of age. 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).
Infant Development - DIACD — At 6 months of age 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).
Change of Baseline in Infant Development - DIACD — At 12 months of age. 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).
Anthropometric Measures of Infant Growth — At 1 to 1.5 months of age. 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.
Change from Baseline in Anthropometric Measures of Infant Growth — At 6 months of age. 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.
Change from Baseline in Anthropometric Measures of Infant Growth — At 12 months of age. 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.
Trial sites (1)
Facility
City
Region
Status
Hospital de Clínicas de Porto Alegre
Porto Alegre
Rio Grande do Sul
More Hospital de Clinicas de Porto Alegre trials in Brazil
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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