Child DevelopmentNCT04713150
HEALthy Brain and Child Development Study - COVID-19 Supplement
An observational study of Child Development and Prenatal Infection, run by Boston Children's Hospital at 4 sites in United States.
Trial summary
The purpose of this study is to advance the scientific understanding of how a prenatal COVID-19 infection and associated psychological distress influences infant neurodevelopment. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Child Development, Prenatal Infection, Prenatal Stress
- How many people
- 62 participants
- Where
- 4 sitesUnited States
- Study dates
- 5 Oct 2020to 14 Sep 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Infants born to COVID-19-positive and COVID-19-negative women.
Who may be able to join
- English or Spanish- speaking of any ethnicity
- Women, aged 18 or older
- Women who received COVID-19 diagnoses during pregnancy OR Women without any SARS-CoV-2 positive test during pregnancy, any suspected COVID illness (even if not tested) or who received a negative COVID-19 test result during pregnancy
Who cannot join
- Participants will be excluded if the child:
- is born at less than 34 weeks or if birth weight is not appropriate for dates
- has an identified genetic, metabolic, syndromic or progressive neurological disorder (e.g., Down Syndrome, Rett Syndrome, Tuberous Sclerosis, Neurofibromatosis, Fragile X Syndrome) at birth or within the first year
Trial locations and contacts
4 sites in 1 country.
United States4 sites
Massachusetts General Hospital
Boston, Massachusetts, 02114
Brigham and Women's Hospital
Boston, Massachusetts, 02115
Laboratories of Cognitive Neuroscience, Boston Children's Hospital
Boston, Massachusetts, 02115
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02215
About this study
The purpose of this study is to advance the scientific understanding of how a prenatal COVID-19 infection and associated psychological distress influences infant neurodevelopment. This project will aim to shed light on how families and child development are impacted by the current COVID-19 pandemic and will work to better support these families and children as they grow.
Read the detailed description
Prenatal exposure to maternal illness and stress has been widely associated with adverse neurodevelopmental outcomes, including deficits in cognition and socioemotional development. The principal goal of this project utilizes Magnetic Resonance Imaging (MRI), Electroencephalography (EEG), and a variety of behavioral measures to assess brain maturation and neurodevelopment among infants exposed prenatally to COVID-19 and associated high levels of stress. The planned experiments are effective in identifying brain markers that may contribute to resiliency in young infants, determining measures of stress response in relation to a maternal COVID-19 diagnosis, and characterizing the neurodevelopment of those infants born to mothers with a COVID-19 infection.
Specific goals include:
- To determine the prevalence of psychological distress in pregnant women with a confirmed COVID-19 diagnosis and to examine the extent to which existing high risk environments play a role in the susceptibility of heightened psychological distress.
- To examine the effects of prenatal distress and maternal illness/inflammation related to a maternal COVID-19 diagnosis on early structural and functional brain development.
- To characterize neural networks that may have been impacted by a maternal COVID-19 infection and related stress during pregnancy.
- To assess the early neurodevelopment outcomes of infants exposed to elevated prenatal stress related to a maternal COVID-19 diagnosis during pregnancy.
- Conditions
- Child Development, Prenatal Infection, Prenatal Stress, Covid19
- Being tested
- No Intervention
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No InterventionOther
No Intervention
| Study group | Role | What they receive |
|---|---|---|
| COVID-19 Positive During Pregnancy | Sixty mother-child dyads, who have or had a confirmed positive COVID-19 test during pregnancy, will be recruited and enrolled in this study. All women enrolled must be 18 years of age or older. Her child will go on to participate at 2-5 days of age, and again at 3-, 6-, 9-, 12- and 24-months of age. Receives: Other: No Intervention | |
| COVID-19 Negative During Pregnancy | Twenty-five mother-child dyads, who have a confirmed negative COVID-19 test during pregnancy will be recruited and enrolled in the study. Women without any SARS-CoV-2 positive test during pregnancy or any suspected COVID illness, even if not tested, will be enrolled. All women enrolled must be 18 years of age or older. Her child will go on to participate at 3-, 6-, 9-, 12- and 24-months of age. Receives: Other: No Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maternal stress associated with a SARS-CoV-2 diagnosis in pregnancy.
Using the Perceived Stress Scale (scores can range from 0 to 40, with higher scores indicating greater stress).
Measured: 9 months (Third trimester - 6 month postnatal visit)
Maternal mental health associated with a SARS-CoV-2 diagnosis in pregnancy.
Using the Edinburgh Postnatal Depression Scale (scores range from 0-30, with higher scores indicating greater feelings of depression).
Measured: 30 months (Third trimester - 24 month postnatal visit)
Inventory of maternal experience associated with a SARS-CoV-2 diagnosis in pregnancy.
Using the Recent Life Events Questionnaire (indexes 30 common life events that encompass both positive and negative events).
Measured: 30 months (Third trimester - 24 month postnatal visit)
Inventory of maternal experience related to healthcare associated with a SARS-CoV-2 diagnosis in pregnancy.
Using the COPE Survey (50-item inventory of experiences for new or expectant mothers during the COVID-19 pandemic; psychometric properties and scoring procedures for this measure have yet to be determined).
Measured: 30 months (Third trimester - 24 month postnatal visit)
Global cognitive ability of offspring
Using the Mullen Scales of Early Learning at 3 months and 6 months postnatally. Five skill areas are measured: Gross Motor and four cognitive skills. These cognitive skill are summarized into an Early Learning Composite (scores are permitted to range from 20 to 80) - Fine Motor, Visual Reception, Receptive Language, and Expressive Language. The raw scores for each scale can be converted into age-adjusted normalized scores.
Measured: 3 months, 6 months, 9 months, 12 months, and 24 months
Neural networks of offspring
Using Electroencephalography at 3 months and 6 months postnatally
Measured: 3 months, 6 months, 9 months, 12 months, and 24 months
Early structural and functional brain development of offspring
Using MRI imaging, which will be obtained at 1-2 days of life
Measured: 1-2 days of life and/or 3-9 months of life
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jan 2021
- Study start5 Oct 2020
- Primary completion14 Sep 2023
- Study completion14 Sep 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Child DevelopmentStudies of the same condition, open and under way.
- More trials run by Boston Children's HospitalThe 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
- Cross-sectional
- Enrolment
- 62 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boston Children's Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Brigham and Women's Hospital, Massachusetts General Hospital
- Responsible party
- Principal investigator, Charles Alexander Nelson III, Boston Children's Hospital
- Investigators
- Charles A Nelson, PhD, Principal investigator, Boston Children's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04713150
- Sponsor's protocol ID
- P00035929
- Status last verified
- Sep 2023
- First submitted
- 17 Dec 2020
- Last updated
- 6 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 6 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- HEALthy Brain and Child Development Study - COVID-19 Supplement
- ClinicalTrials.gov ID
- NCT04713150
- Acronym / sponsor ID
- P00035929
- Conditions
- Child Development, Prenatal Infection, Prenatal Stress, Covid19
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 62 participants (actual)
- Lead sponsor
- Boston Children's HospitalUniversity, hospital or other
- Collaborators
- Brigham and Women's Hospital, Massachusetts General Hospital
- Study start
- 5 Oct 2020 (actual)
- Primary completion
- 14 Sep 2023 (actual)
- Study completion
- 14 Sep 2023 (actual)
- First posted
- 19 Jan 2021 (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.
The purpose of this study is to advance the scientific understanding of how a prenatal COVID-19 infection and associated psychological distress influences infant neurodevelopment. This project will aim to shed light on how families and child development are impacted by the current COVID-19 pandemic and will work to better support these families and children as they grow.
Detailed description
Prenatal exposure to maternal illness and stress has been widely associated with adverse neurodevelopmental outcomes, including deficits in cognition and socioemotional development. The principal goal of this project utilizes Magnetic Resonance Imaging (MRI), Electroencephalography (EEG), and a variety of behavioral measures to assess brain maturation and neurodevelopment among infants exposed prenatally to COVID-19 and associated high levels of stress. The planned experiments are effective in identifying brain markers that may contribute to resiliency in young infants, determining measures of stress response in relation to a maternal COVID-19 diagnosis, and characterizing the neurodevelopment of those infants born to mothers with a COVID-19 infection.
Specific goals include:
- To determine the prevalence of psychological distress in pregnant women with a confirmed COVID-19 diagnosis and to examine the extent to which existing high risk environments play a role in the susceptibility of heightened psychological distress.
- To examine the effects of prenatal distress and maternal illness/inflammation related to a maternal COVID-19 diagnosis on early structural and functional brain development.
- To characterize neural networks that may have been impacted by a maternal COVID-19 infection and related stress during pregnancy.
- To assess the early neurodevelopment outcomes of infants exposed to elevated prenatal stress related to a maternal COVID-19 diagnosis during pregnancy.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| COVID-19 Positive During Pregnancy | – | Other: No InterventionSixty mother-child dyads, who have or had a confirmed positive COVID-19 test during pregnancy, will be recruited and enrolled in this study. All women enrolled must be 18 years of age or older. Her child will go on to participate at 2-5 days of age, and again at 3-, 6-, 9-, 12- and 24-months of age. |
| COVID-19 Negative During Pregnancy | – | Other: No InterventionTwenty-five mother-child dyads, who have a confirmed negative COVID-19 test during pregnancy will be recruited and enrolled in the study. Women without any SARS-CoV-2 positive test during pregnancy or any suspected COVID illness, even if not tested, will be enrolled. All women enrolled must be 18 years of age or older. Her child will go on to participate at 3-, 6-, 9-, 12- and 24-months of age. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Infants born to COVID-19-positive and COVID-19-negative women.
Key inclusion criteria (3 listed)
- English or Spanish- speaking of any ethnicity
- Women, aged 18 or older
- Women who received COVID-19 diagnoses during pregnancy OR Women without any SARS-CoV-2 positive test during pregnancy, any suspected COVID illness (even if not tested) or who received a negative COVID-19 test result during pregnancy
Key exclusion criteria (3 listed)
- is born at less than 34 weeks or if birth weight is not appropriate for dates
- has an identified genetic, metabolic, syndromic or progressive neurological disorder (e.g., Down Syndrome, Rett Syndrome, Tuberous Sclerosis, Neurofibromatosis, Fragile X Syndrome) at birth or within the first year
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| No InterventionNo Intervention | Other | COVID-19 Negative During Pregnancy, COVID-19 Positive During Pregnancy |
Primary outcome
Maternal stress associated with a SARS-CoV-2 diagnosis in pregnancy.
Time frame: 9 months (Third trimester - 6 month postnatal visit)
Using the Perceived Stress Scale (scores can range from 0 to 40, with higher scores indicating greater stress).
Maternal mental health associated with a SARS-CoV-2 diagnosis in pregnancy.
Time frame: 30 months (Third trimester - 24 month postnatal visit)
Using the Edinburgh Postnatal Depression Scale (scores range from 0-30, with higher scores indicating greater feelings of depression).
Inventory of maternal experience associated with a SARS-CoV-2 diagnosis in pregnancy.
Time frame: 30 months (Third trimester - 24 month postnatal visit)
Using the Recent Life Events Questionnaire (indexes 30 common life events that encompass both positive and negative events).
Inventory of maternal experience related to healthcare associated with a SARS-CoV-2 diagnosis in pregnancy.
Time frame: 30 months (Third trimester - 24 month postnatal visit)
Using the COPE Survey (50-item inventory of experiences for new or expectant mothers during the COVID-19 pandemic; psychometric properties and scoring procedures for this measure have yet to be determined).
Global cognitive ability of offspring
Time frame: 3 months, 6 months, 9 months, 12 months, and 24 months
Using the Mullen Scales of Early Learning at 3 months and 6 months postnatally. Five skill areas are measured: Gross Motor and four cognitive skills. These cognitive skill are summarized into an Early Learning Composite (scores are permitted to range from 20 to 80) - Fine Motor, Visual Reception, Receptive Language, and Expressive Language. The raw scores for each scale can be converted into age-adjusted normalized scores.
Neural networks of offspring
Time frame: 3 months, 6 months, 9 months, 12 months, and 24 months
Using Electroencephalography at 3 months and 6 months postnatally
Early structural and functional brain development of offspring
Time frame: 1-2 days of life and/or 3-9 months of life
Using MRI imaging, which will be obtained at 1-2 days of life
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Apr 2026.
- Individual participant dataSharing planned: Undecided
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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. This study is not recruiting at the moment.
Charles A Nelson, PhD principal investigator
Boston Children's Hospital
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Child Development and Prenatal Infection, run by Boston Children's Hospital at 4 sites in United States.
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 3 inclusion and 3 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: finished, as of the sponsor's last update on 6 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United States. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Maternal stress associated with a SARS-CoV-2 diagnosis in pregnancy. (time frame: 9 months (Third trimester - 6 month postnatal visit)). The study lists 7 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 6 Apr 2026.