Effects of Light Exposure for Postpartum Depression on Infant Development
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Development and Health, Nutrition. Basic parameters: No limits · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Brazil
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
The Impact of Non-Pharmacological Treatment (Exposure to Light) for Postpartum Depression on Infant Growth and Development
Overview
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.
Detailed description
Currently, it is estimated that approximately 11% of women develop mood disorders in the postpartum period, presenting symptoms of both depression and anxiety, which are associated with a worsened quality of life and reduced maternal functioning. Postpartum depression has an impact on child health, directly and indirectly affecting growth and development.
Studies evaluating blue light exposure treatment, based on principles of chronobiology, are still scarce; however, some have reported promising results, in addition to lower cost and absence of side effects. Nevertheless, the impact of this maternal intervention on child growth and development remains unknown.
The hypothesis of the present project is that children born to mothers treated with blue light exposure for postpartum depression will show better growth and development during the first year of life. Accordingly, the aim of this study is to evaluate the growth and development of children born to mothers under these conditions: Mothers diagnosed with postpartum depression up to the infant's sixth week of life will be allocated to two light-exposure therapy groups (an intervention/therapeutic group and a control light-exposure group from another research study - NCT06246214), in addition to a control group of mothers without postpartum depression and a group with previous depression.
Children will be followed until 12 months of age, at which point multiple nutritional, growth, and developmental measures will be collected.
Data analyses will be conducted using association tests and linear regression models, with child growth and developmental outcomes as the primary endpoints.
Primary outcome measures
- Infant Development - Bayley [Time frame: At 1 to 1.5 months of age.]
- Change from Baseline in Infant Development - Bayley [Time frame: At 6 months of age.]
- Change from Baseline in Infant Development - Bayley [Time frame: At 12 months of age.]
- Infant Development - DIACD [Time frame: At 6 months of age]
- Change of Baseline in Infant Development - DIACD [Time frame: At 12 months of age.]
- Anthropometric Measures of Infant Growth [Time frame: At 1 to 1.5 months of age.]
- Change from Baseline in Anthropometric Measures of Infant Growth [Time frame: At 6 months of age.]
- Change from Baseline in Anthropometric Measures of Infant Growth [Time frame: At 12 months of age.]
Secondary outcome measures (11)
- Breastfeeding Self-Efficacy - BSES [Time frame: At 1 to 1.5 months of age.]
- Infant feeding practices - BEBQ [Time frame: At 6 months of age.]
- Infant feeding practices - CEBQ [Time frame: At 12 months of age.]
- Infant sleep problems - BISQ [Time frame: At 6 months of age.]
- Change from Baseline in Infant sleep problems - BISQ [Time frame: At 12 months of age.]
- Mother-infant interaction quality - Dyadic Interaction Assessment Protocol [Time frame: At 6 months of age.]
- Change from Baseline in Mother-infant interaction quality - Dyadic Interaction Assessment Protocol [Time frame: At 12 months of age.]
- Mother-infant interaction quality - The Interaction Rating Scale (IRS) [Time frame: At 6 months of age.]
- 15. Change from Baseline in Mother-infant interaction quality - The Interaction Rating Scale (IRS) [Time frame: At 12 months of age.]
- Infant screen exposure [Time frame: At 6 months of age.]
- Change from Baseline in Infant screen exposure [Time frame: At 12 months of age.]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Observational model
- Cohort
Study locations
Brazil · 1 center
- Hospital de Clínicas de Porto Alegre — Porto Alegre
Identifiers
NCT: NCT07440355 · 2024-0089 · CAAE 78853224.5.0000.5327 · 405657/2023-4