Development and HealthChrono_BabyNCT07440355
Effects of Light Exposure for Postpartum Depression on Infant Development
An observational study of Development and Health and Nutrition, run by Hospital de Clinicas de Porto Alegre at 1 site in Brazil.
Trial 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. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Development and Health, Nutrition
- How many people
- 200 participants
- Where
- 1 siteBrazil
- Study dates
- 26 Aug 2024to 30 Aug 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: Infants born to women 18 years or older, who speak fluent Portuguese and are 4 to 6 weeks postpartum, will participate.
Who may be able to join
- 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.
Who cannot join
- Late preterm newborns (gestational age < 33 weeks)
- Adverse peri- and neonatal outcomes:
- periventricular hemorrhage,
- leukomalacia,
- cardiorespiratory arrest,
- resuscitation,
Show all 10Show fewer
- mechanical ventilation,
- genetic syndromes
- congenital malformations
- Vertical HIV exposure.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Brazil1 site
Hospital de Clínicas de Porto Alegre
Porto Alegre, Rio Grande do Sul, 90410-000
About this study
Official title: The Impact of Non-Pharmacological Treatment (Exposure to Light) for Postpartum Depression on Infant Growth and Development
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.
Read the 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.
- Conditions
- Development and Health, Nutrition
- Keywords
- child development, postpartum depression, light therapy, child growth
- Medical subject headings
- Depression, Postpartum
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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.
Measured: 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.
Measured: 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.
Measured: At 12 months of age.
Secondary outcomes (11)
Breastfeeding Self-Efficacy - BSES
Mothers will also be assessed with respect to their beliefs, expectations, knowledge, and ability to breastfeed successfully. To address this goal, the Breastfeeding Self-Efficacy Scale (BSES; Dennis \& Faux, 1999), validated for the Brazilian population (Oriá \& Ximenes, 2010), will be used. The BSES is organized into four informational sources: personal experience, verbal persuasion, vicarious experience, and emotional/physiological state. The BSES is a self-administered questionnaire composed of 33 items rated on a 5-point Likert scale (range from strongly agree to "strongly disagree). Total scores (ranging from 33 to 165) are provided; higher scores reflect confidence in breastfeeding ability
Measured: At 1 to 1.5 months of age.
Infant feeding practices - BEBQ
Infant feeding practices measured by the Baby Eating Behavior Questionnaire (BEBQ: Lucion et al., 2017).) validated for the Brazilian population. This questionnaire examines specific appetite traits in children (ages 0 to 12 months), before the introduction of solid foods, within four domains: enjoyment of food, food responsiveness, speed of eating, and satiety responsiveness. The BEBQ is a self-administered instrument comprising 18 items and can be used regardless of breastfeeding type. Scale scores are the means of all scale items. Higher scores indicate more frequent demonstrations of behaviors characterizing the domain.
Measured: At 6 months of age.
Infant feeding practices - CEBQ
The Children's Eating Behavior Questionnaire (CEBQ; Wardle et al., 2001), validated for the Brazilian population (Viana, Sinde \& Saxton, 2008), will be used to assess the eating behavior of children at 12 months; the mothers will complete the questionnaire. This is a self-administered instrument consisting of 35 items, in two dimensions: Food Avoidance assessed throughout four subscales (e.g., Satiety Responsiveness, Slowness in Eating, Food Fussiness, and Emotional Under-Eating) and Food Approach also assessed with four subscales (Food Responsiveness, Enjoyment of Food, Emotional Over-Eating, and Desire to Drink). Responses are provided on a 5-point Likert scale ranging from "never" to "always. Scale scores are the means of all scale items. Higher scores indicate more frequent demonstrations of behaviors characterizing the subscales.
Measured: At 12 months of age.
Infant sleep problems - BISQ
The Brief Infant Sleep Questionnaire (BISQ; Sadeh, 2004) will be used to screen children sleep problems. The BISQ was developed in children aged 0 to 3 years. It is a semi-structured questionnaire consisting of 12 items related to the child's sleep in the past week, completed by parents or caregivers. It takes about 10 minutes to complete. Its validity and reliability were originally confirmed by comparisons with actigraphy and sleep diaries (Sadeh, 2004). The instrument was translated into Brazilian Portuguese by Nunes et al. (2012) and validated in a Brazilian study showing high specificity for sleep-related parameters, supporting parental reports for epidemiological research (Dal-Ponte et al., 2020). The criteria used to define poor sleepers based on the BISQ measures are as follows: 1) the child wakes > 3 times per night; 2) the nocturnal wakefulness period is > 1 hour; or 3) the total sleep time is < 9 hours.
Measured: At 6 months of age.
Change from Baseline in Infant sleep problems - BISQ
The Brief Infant Sleep Questionnaire (BISQ; Sadeh, 2004) will be used to screen children sleep problems. The BISQ was developed in children aged 0 to 3 years. It is a semi-structured questionnaire consisting of 12 items related to the child's sleep in the past week, completed by parents or caregivers. It takes about 10 minutes to complete. Its validity and reliability were originally confirmed by comparisons with actigraphy and sleep diaries (Sadeh, 2004). The instrument was translated into Brazilian Portuguese by Nunes et al. (2012) and validated in a Brazilian study showing high specificity for sleep-related parameters, supporting parental reports for epidemiological research (Dal-Ponte et al., 2020). The criteria used to define poor sleepers based on the BISQ measures are as follows: 1) the child wakes > 3 times per night; 2) the nocturnal wakefulness period is > 1 hour; or 3) the total sleep time is < 9 hours.
Measured: At 12 months of age.
Mother-infant interaction quality - Dyadic Interaction Assessment Protocol
The Dyadic Interaction Assessment Protocol (DIAP) is a bidirectional measure of adult-child interaction based on Ainsworth and Cox and validated in Brazil. It involves a standardized seven-minute free-play task in which caregiver-child behavior is coded across ten categories grouped into dyadic characteristics (child engagement with the environment, interaction with the caregiver, positive and negative affect, and caregiver sensitivity and intrusiveness) and adult characteristics (positive and negative affect, cognitive stimulation, and disengagement). The instrument demonstrates strong psychometric properties, including adequate interrater reliability, internal consistency, and convergent validity. Sessions follow the original free-play procedure with mother and infant, are video recorded with caregiver consent, coded by trained raters blinded to study variables using standardized guidelines, and disagreements are resolved by a third independent evaluator to ensure coding reliability
Measured: At 6 months of age.
Change from Baseline in Mother-infant interaction quality - Dyadic Interaction Assessment Protocol
The Dyadic Interaction Assessment Protocol (DIAP) is a bidirectional measure of adult-child interaction based on Ainsworth and Cox and validated in Brazil. It involves a standardized seven-minute free-play task in which caregiver-child behavior is coded across ten categories grouped into dyadic characteristics (child engagement with the environment, interaction with the caregiver, positive and negative affect, and caregiver sensitivity and intrusiveness) and adult characteristics (positive and negative affect, cognitive stimulation, and disengagement). The instrument demonstrates strong psychometric properties, including adequate interrater reliability, internal consistency, and convergent validity. Sessions follow the original free-play procedure with mother and infant, are video recorded with caregiver consent, coded by trained raters blinded to study variables using standardized guidelines, and disagreements are resolved by a third independent evaluator to ensure coding reliability
Measured: At 12 months of age.
Mother-infant interaction quality - The Interaction Rating Scale (IRS)
The Interaction Rating Scale (IRS) assesses caregiver-child interaction in children aged 0-8 years through a structured five-minute observation. It comprises 70 dichotomous behavioral items and 11 impression items rated on a five-point scale, organized into ten factors representing child skills (autonomy, responsiveness, empathy, motor and emotional regulation) and caregiver behaviors (respect for autonomy, responsiveness, empathy, and cognitive and socioemotional support). A total score summarizes overall interaction quality. The IRS is currently undergoing validation in Brazil and, in its original version, demonstrated high interrater reliability and adequate to strong internal consistency. In this study, coding will rely on seven-minute free-play videos, be conducted independently by two trained raters, and discrepancies will be resolved by a third evaluator following standardized training procedures to ensure reliability.
Measured: At 6 months of age.
15. Change from Baseline in Mother-infant interaction quality - The Interaction Rating Scale (IRS)
The Interaction Rating Scale (IRS) assesses caregiver-child interaction in children aged 0-8 years through a structured five-minute observation. It comprises 70 dichotomous behavioral items and 11 impression items rated on a five-point scale, organized into ten factors representing child skills (autonomy, responsiveness, empathy, motor and emotional regulation) and caregiver behaviors (respect for autonomy, responsiveness, empathy, and cognitive and socioemotional support). A total score summarizes overall interaction quality. The IRS is currently undergoing validation in Brazil and, in its original version, demonstrated high interrater reliability and adequate to strong internal consistency. In this study, coding will rely on seven-minute free-play videos, be conducted independently by two trained raters, and discrepancies will be resolved by a third evaluator following standardized training procedures to ensure reliability.
Measured: At 12 months of age.
Infant screen exposure
A Portuguese-adapted version of the questionnaire from the survey Zero to Eight: Children's Media Use in America (Common Sense Media, 2013) will be used. This instrument includes questions regarding the types of media used by both children and caregivers, as well as the duration and frequency of use. The research team at Common Sense Media approved the translation of the questionnaire. For the present study, additional adaptations will be made to better capture the use of specific screens in families with infants aged 0 to 12 months.
Measured: At 6 months of age.
Change from Baseline in Infant screen exposure
A Portuguese-adapted version of the questionnaire from the survey Zero to Eight: Children's Media Use in America (Common Sense Media, 2013) will be used. This instrument includes questions regarding the types of media used by both children and caregivers, as well as the duration and frequency of use. The research team at Common Sense Media approved the translation of the questionnaire. For the present study, additional adaptations will be made to better capture the use of specific screens in families with infants aged 0 to 12 months.
Measured: At 12 months of age.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Feb 2026
- Study start26 Aug 2024
- Primary completion20 Dec 2027 (estimated)
- Study completion30 Aug 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Development and HealthStudies of the same condition, open and under way.
- More trials run by Hospital de Clinicas de Porto AlegreThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospital de Clinicas de Porto Alegre
- Sponsor type
- University, hospital or other
- Collaborators
- Federal University of Rio Grande do Sul, Conselho Nacional de Desenvolvimento Científico e Tecnológico
- Responsible party
- Sponsor
- Investigators
- Clécio H Silva, PhD, Principal investigator, Hospital de Clinicas de Porto Alegre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07440355
- Sponsor's protocol ID
- 2024-0089
- Other IDs
- CAAE 78853224.5.0000.5327, 405657/2023-4
- Acronym
- Chrono_Baby
- Status last verified
- Feb 2026
- First submitted
- 23 Feb 2026
- Last updated
- 27 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of Non-Pharmacological Treatment (Exposure to Light) for Postpartum Depression on Infant Growth and Development
- ClinicalTrials.gov ID
- NCT07440355
- Acronym / sponsor ID
- Chrono_Baby / 2024-0089
- Conditions
- Development and Health, Nutrition
- Keywords
- child development, postpartum depression, light therapy, child growth
- Study type
- Observational
- Recruitment status
- Enrolling by invitation
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Hospital de Clinicas de Porto AlegreUniversity, hospital or other
- Collaborators
- Federal University of Rio Grande do Sul, Conselho Nacional de Desenvolvimento Científico e Tecnológico
- Study start
- 26 Aug 2024 (actual)
- Primary completion
- 20 Dec 2027 (estimated)
- Study completion
- 30 Aug 2028 (estimated)
- First posted
- 27 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Infants born to women 18 years or older, who speak fluent Portuguese and are 4 to 6 weeks postpartum, will participate.
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (10 listed)
- Late preterm newborns (gestational age < 33 weeks)
- Adverse peri- and neonatal outcomes:
- periventricular hemorrhage,
- leukomalacia,
- cardiorespiratory arrest,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Infant Development - Bayley
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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.
11 secondary outcomes
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Feb 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Clécio H Silva, PhD principal investigator
Hospital de Clinicas de Porto Alegre
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Development and Health and Nutrition, run by Hospital de Clinicas de Porto Alegre at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 27 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Infant Development - Bayley (time frame: At 1 to 1.5 months of age.). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Feb 2026.