Effects of Light Exposure for Postpartum Depression on Infant Development

Официальное название

The Impact of Non-Pharmacological Treatment (Exposure to Light) for Postpartum Depression on Infant Growth and Development

Обзор

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.

Подробное описание

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.

Первичные конечные точки

• Infant Development - Bayley [Срок оценки: At 1 to 1.5 months of age.]
• Change from Baseline in Infant Development - Bayley [Срок оценки: At 6 months of age.]
• Change from Baseline in Infant Development - Bayley [Срок оценки: At 12 months of age.]
• Infant Development - DIACD [Срок оценки: At 6 months of age]
• Change of Baseline in Infant Development - DIACD [Срок оценки: At 12 months of age.]
• Anthropometric Measures of Infant Growth [Срок оценки: At 1 to 1.5 months of age.]
• Change from Baseline in Anthropometric Measures of Infant Growth [Срок оценки: At 6 months of age.]
• Change from Baseline in Anthropometric Measures of Infant Growth [Срок оценки: At 12 months of age.]

Вторичные конечные точки (11)

• Breastfeeding Self-Efficacy - BSES [Срок оценки: At 1 to 1.5 months of age.]
• Infant feeding practices - BEBQ [Срок оценки: At 6 months of age.]
• Infant feeding practices - CEBQ [Срок оценки: At 12 months of age.]
• Infant sleep problems - BISQ [Срок оценки: At 6 months of age.]
• Change from Baseline in Infant sleep problems - BISQ [Срок оценки: At 12 months of age.]
• Mother-infant interaction quality - Dyadic Interaction Assessment Protocol [Срок оценки: At 6 months of age.]
• Change from Baseline in Mother-infant interaction quality - Dyadic Interaction Assessment Protocol [Срок оценки: At 12 months of age.]
• Mother-infant interaction quality - The Interaction Rating Scale (IRS) [Срок оценки: At 6 months of age.]
• 15. Change from Baseline in Mother-infant interaction quality - The Interaction Rating Scale (IRS) [Срок оценки: At 12 months of age.]
• Infant screen exposure [Срок оценки: At 6 months of age.]
• Change from Baseline in Infant screen exposure [Срок оценки: At 12 months of age.]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Модель наблюдения

Когортное

Центры проведения

Бразилия · 1 центр

• Hospital de Clínicas de Porto Alegre — Porto Alegre

Идентификаторы

NCT: NCT07440355 · 2024-0089 · CAAE 78853224.5.0000.5327 · 405657/2023-4

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗