Prenatal Exposure Delayed EffectsNCT06296238
Nutrition and Inflammation in Pregnancy: Impacts on Early Human Brain Development in Ethiopia
An observational study of Prenatal Exposure Delayed Effects, run by Brown University at 1 site in Ethiopia.
Trial summary
The goal of this observational child follow-up study is to examine the effects of prenatal nutrition and infection management interventions on long-term child neurodevelopment. Participants are the offspring of mothers in the main study entitled "Enhancing Nutrition and Antenatal Infection Treatment (ENAT)" that was… Read more about this study
- Who is it for?
- Ages 9 to 27 monthsHealthy volunteers can take part
- Conditions the study is for
- Prenatal Exposure Delayed Effects
- Type of treatment
- Pill or oral medicine
- How many people
- 463 participants
- Where
- 1 siteEthiopia
- Study dates
- 15 Feb 2023to 1 Jul 2024
- 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 9 to 27 months
- All sexes
- Healthy volunteers accepted
- Child
Study population: The participants of this study will be recruited from 6 rural health centers (serving a ~25,000 population) involved in ENAT study in West Gojjam and South Gondar zones, Amhara, Ethiopia (Lee et al., 2022). In this infant follow-up study, up to 500 selected infants from the parent ENAT study will be followed for 24 months for general health, growth, and development. A subset of these infants (up to 480) whose mothers provided biospecimens or whose mothers had mid-upper arm circumference (MUAC) of <23 cm in the parent study will be recruited for an advanced neurodevelopmental assessment study.
Who may be able to join
- Mothers who have participated in ENAT study who consent to participate in the infant follow up study
- Intention to stay in the study catchment area
- Healthy infants without severe clinical signs or symptoms including headache, vomiting, or dizziness
Who cannot join
- Major congenital anomalies
- Infants with severe morbidity or developmental disorder
- Neonatal encephalopathy
- Plan to move out of study catchment area
Trial locations and contacts
1 site in 1 country.
Ethiopia1 site
Health Centers in West Gojjam and South Gondar zones
Bahir Dar, Amhara
About this study
The goal of this observational child follow-up study is to examine the effects of prenatal nutrition and infection management interventions on long-term child neurodevelopment.
Participants are the offspring of mothers in the main study entitled "Enhancing Nutrition and Antenatal Infection Treatment (ENAT)" that was conducted in the rural Amhara region of Ethiopia. In the ENAT pragmatic clinical effectiveness study, 2399 pregnant women were randomized to receive routine prenatal care, a package of enhanced nutrition interventions (balanced energy protein supplement, iodized salt, iron-folic acid and counseling), a package of enhanced infection management interventions (genitourinary tract infection screening-treatment, deworming), or a combination of both packages. The impact of these antenatal nutrition and infection interventions on birth outcomes (infant birth size and gestational length) was examined in the main study. In this longitudinal cohort study, we will follow the offspring from the ENAT pregnancy cohort up to 24 months postnatal age and assess their growth, health and neurodevelopment.
Read more
The main questions it aims to answer are:
- What are the effects of pregnancy interventions from the parent study (ENAT) on offspring neurodevelopmental outcomes?
- What are the associations between maternal-newborn iron status and inflammation on infant neurodevelopment?
- What are the associations between maternal iodine status and thyroid function on infant neurodevelopment?
We will follow children of mothers from the parent ENAT study to monitor their growth, health, and neurodevelopment up to 24 months postnatal age.
Read the detailed description
In low-resource settings, undernutrition and infections during the first 1000 days of life are prevalent, modifiable risk factors that may have lifelong effects on a child's cognitive and psychological development, yet effective interventions addressing prevailing mechanisms are still to be validated. Iron, protein and energy are critical nutrients that support the rapidly developing fetal brain, however, among women of reproductive age in Sub-Saharan Africa, 10% are underweight and 20% have iron deficiency anemia. Pregnancy infections are also common in Africa, where one in three women have a geo-helminthic infection resulting in blood loss, iron deficiency and inflammation. The interaction between iron and inflammation in pregnancy is particularly complex. NICHD has identified the complex relationship between nutrition, inflammation, and neurodevelopment as a major research gap. A barrier to progress is that mechanistic understanding of prenatal brain development is based on animal or observational studies. We present a unique opportunity to leverage an ongoing randomized controlled trial (RCT) to examine the consequences of pregnancy nutrition and inflammation on child neurodevelopment.
The Enhancing Nutrition and Antenatal Infection Treatment (ENAT) RCT enrolled pregnant women in Amhara, Ethiopia to study independent and overlapping effects of prenatal nutrition and infection interventions on birth outcomes. Women were randomized to receive: 1) standard prenatal care, 2) enhanced nutrition package (ENP) (counseling, iron-folic acid [IFA], iodized salt, and balanced energy protein [BEP] supplementation), 3) enhanced infection management package (EIMP) (anti-helminthics, urinary tract infection treatment), or 4) ENP+EIMP. The current follow-up study (Longitudinal Infant Development and Growth; LIDG) will investigate biological pathways by which ENAT interventions, specifically iron, protein-energy, and inflammation, influence child neurodevelopment.
Our overarching hypotheses are that improving prenatal nutrition will improve brain structural and network development, reducing inflammation will improve white matter maturation, and the combination will have synergistic effects on child neuro-cognitive outcomes. This study will follow up to 500 ENAT children to assess neurodevelopment through 24 months of age, including neurobehavior and neural networks.
- Conditions
- Prenatal Exposure Delayed Effects
- Medical subject headings
- Prenatal Exposure Delayed Effects
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 |
|---|---|---|
| Enhanced Nutrition Package (ENP) health center + Enhanced Infection Management Package (EIMP) | ENP: Health centers were strengthened to provide WHO/FMOH-recommended nutrition interventions in pregnancy. Pregnant women received a supply of adequately iodized salt for household use and iron-folate tablets from enrollment to birth. Women with undernutrition (MUAC <23 cm), also received a daily balanced energy protein supplement. EIMP: Pregnant women were screened at enrollment for bacteriuria with urine culture and antimicrobial susceptibility testing and presumptive deworming with mebendazole 500mg. Some women also received screening for chlamydia and gonorrhea and symptomatic women were tested for bacterial vaginosis and trichomonas. For women with chlamydia or gonorrhea, the participant was treated per FMOH guidelines with recommended antibiotics. STI/RTI screening was eventually discontinued due to supply shortage and the low prevalence of STI. At ANC follow-up visits, infected women were treated with antibiotics and persistent infection was retreated. | |
| ENP health center, routine care infection management participant | ENP: The health centers were strengthened to provide WHO/FMOH-recommended nutrition interventions in pregnancy. Pregnant women received a supply of adequately iodized salt for household use and iron-folate tablets from enrollment to birth. Women with undernutrition (MUAC <23 cm), also received a daily balanced energy protein supplement. Standard infection care: Maternal genitourinary tract infections is managed as per standard FMOH health center guidelines that utilize a syndromic management approach. | |
| Routine nutrition care health center, EIMP participant | Routine nutrition care: Maternal nutrition was managed as per standard FMOH health center guidelines. EIMP: Pregnant women were screened at enrollment for bacteriuria with urine culture and antimicrobial susceptibility testing and presumptive deworming with mebendazole 500mg. Some women also received screening for chlamydia and gonorrhea and symptomatic women were tested for bacterial vaginosis and trichomonas. For women with chlamydia or gonorrhea, the participant (and partner) was treated per FMOH guidelines with recommended antibiotics. STI/RTI screening was eventually discontinued due to supply shortage and the low prevalence of STI. At ANC follow-up visits, infected women were treated with antibiotics and persistent infection was retreated. | |
| Routine of care nutrition and infection management | Pregnant women received routine strengthened antenatal care services at the health center per FMOH guidelines. Maternal genitourinary tract infections were managed as per standard FMOH health center guidelines that utilize a syndromic management approach. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Child resting brain function
Measured by absolute power of alpha frequency band on mobile electroencephalography
Measured: 24 months
Secondary outcomes (12)
Child resting brain function, secondary measures
Absolute power of theta band (3-5 Hz) as measured on mobile EEG
Measured: 24 months
Neural processing speed
VEP P1 peak latency (ms)
Measured: 24 months
Visual Attention
Measured with infant eye tracking during Cecile Attention Task
Measured: 12 months
Nonverbal Visual Attention
Multisensory Attention Assessment Protocol
Measured: 12 months
Infant Neurologic Maturity
Hammersmith Infant Neurological Exam (HINE) Total Score
Measured: 12 months
Child Cognitive Function
Bayley-III Cognitive Scale
Measured: 24 months
Child size
Length for age Z score [standard deviations from the median for age and sex, range: -5 (worse) to +5 (better)]
Measured: 24 months
Child Size
Weight for age z score [standard deviations from the median for age and sex, range: -5 (worse) to +5 (better)]
Measured: 24 months
Child Size
Head circumference for age z score [standard deviations from the median for age and sex, range: -5 (worse) to +5 (better)]
Measured: 24 months
Child Size
Body mass index
Measured: 24 months
Brain Structure
Total brain volume (cm3); regional volumes measure by hyperfine low field MRI
Measured: 12 months
Child Morbidity
Fever, diarrhea, hospitalization
Measured: 12 and 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Mar 2024
- Study start15 Feb 2023
- Primary completion1 Jul 2024
- Study completion1 Jul 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Prenatal Exposure Delayed EffectsStudies of the same condition, open and under way.
- More trials run by Brown UniversityThe 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
- 463 participants (actual)
Sponsor and investigators
- Lead sponsor
- Brown University
- Sponsor type
- University, hospital or other
- Collaborators
- Addis Continental Institute of Public Health, Boston Children's Hospital, New York University, Johns Hopkins University, Brigham and Women's Hospital
- Responsible party
- Principal investigator, Anne Shee CC Lee, Brown University
- Investigators
- Yemane Berhane, Principal investigator, Addis Continental Institute of Public HealthAnne CC Lee, Principal investigator, Warren Alpert Medical School of Brown University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06296238
- Sponsor's protocol ID
- 2023P000461
- Status last verified
- Mar 2025
- First submitted
- 29 Feb 2024
- Last updated
- 23 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Roy Paladhi U, Workneh F, Baye E, Derebe MM, Yibeltal K, Fasil N, Driker S, Van Dyk F, I Chin T, North K, Jensen SKG, Christian P, Worku A, Berhane Y, Lee AC. Investigating biological mechanisms of adverse birth outcomes and early child development in Amhara, Ethiopia: protocol of biospecimen collection and analysis of the Enhancing Nutrition and Antenatal Infection Treatment (ENAT) randomised effectiveness study. BMJ Open. 2025 Apr 28;15(4):e098686. doi: 10.1136/bmjopen-2024-098686.
PubMed 40295129Workneh F, Chin TI, Yibeltal K, Fasil N, North K, Jensen SKG, Kidane WT, Melese M, Tsegaye S, Berhane YY, Roy Paladhi U, Abate BH, Teklehaimanot A, Melka TL, Pihl S, An WW, Van Dyk F, Mullany LC, Folger LV, Cherkerzian S, Troller-Renfree SV, Thomason ME, Andersson M, Inder T, Nelson CA, Grant PE, Christian P, Worku A, Berhane Y, Lee AC. Impact of maternal antenatal nutrition and infection treatment interventions on Longitudinal Infant Development and Growth in rural Ethiopia: protocol of the LIDG child follow-up study. BMJ Paediatr Open. 2024 Dec 24;8(1):e002840. doi: 10.1136/bmjpo-2024-002840.
PubMed 39725450
Study at a glance
From the registry record, last updated by the sponsor on 23 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Nutrition and Inflammation in Pregnancy: Impacts on Early Human Brain Development in Ethiopia
- ClinicalTrials.gov ID
- NCT06296238
- Acronym / sponsor ID
- 2023P000461
- Conditions
- Prenatal Exposure Delayed Effects
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 463 participants (actual)
- Lead sponsor
- Brown UniversityUniversity, hospital or other
- Collaborators
- Addis Continental Institute of Public Health, Boston Children's Hospital, New York University, Johns Hopkins University, Brigham and Women's Hospital
- Study start
- 15 Feb 2023 (actual)
- Primary completion
- 1 Jul 2024 (actual)
- Study completion
- 1 Jul 2024 (actual)
- First posted
- 6 Mar 2024 (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 goal of this observational child follow-up study is to examine the effects of prenatal nutrition and infection management interventions on long-term child neurodevelopment.
Participants are the offspring of mothers in the main study entitled "Enhancing Nutrition and Antenatal Infection Treatment (ENAT)" that was conducted in the rural Amhara region of Ethiopia. In the ENAT pragmatic clinical effectiveness study, 2399 pregnant women were randomized to receive routine prenatal care, a package of enhanced nutrition interventions (balanced energy protein supplement, iodized salt, iron-folic acid and counseling), a package of enhanced infection management interventions (genitourinary tract infection screening-treatment, deworming), or a combination of both packages. The impact of these antenatal nutrition and infection interventions on birth outcomes (infant birth size and gestational length) was examined in the main study. In this longitudinal cohort study, we will follow the offspring from the ENAT pregnancy cohort up to 24 months postnatal age and assess their growth, health and neurodevelopment.
The main questions it aims to answer are:
- What are the effects of pregnancy interventions from the parent study (ENAT) on offspring neurodevelopmental outcomes?
- What are the associations between maternal-newborn iron status and inflammation on infant neurodevelopment?
- What are the associations between maternal iodine status and thyroid function on infant neurodevelopment?
We will follow children of mothers from the parent ENAT study to monitor their growth, health, and neurodevelopment up to 24 months postnatal age.
Detailed description
In low-resource settings, undernutrition and infections during the first 1000 days of life are prevalent, modifiable risk factors that may have lifelong effects on a child's cognitive and psychological development, yet effective interventions addressing prevailing mechanisms are still to be validated. Iron, protein and energy are critical nutrients that support the rapidly developing fetal brain, however, among women of reproductive age in Sub-Saharan Africa, 10% are underweight and 20% have iron deficiency anemia. Pregnancy infections are also common in Africa, where one in three women have a geo-helminthic infection resulting in blood loss, iron deficiency and inflammation. The interaction between iron and inflammation in pregnancy is particularly complex. NICHD has identified the complex relationship between nutrition, inflammation, and neurodevelopment as a major research gap. A barrier to progress is that mechanistic understanding of prenatal brain development is based on animal or observational studies. We present a unique opportunity to leverage an ongoing randomized controlled trial (RCT) to examine the consequences of pregnancy nutrition and inflammation on child neurodevelopment.
The Enhancing Nutrition and Antenatal Infection Treatment (ENAT) RCT enrolled pregnant women in Amhara, Ethiopia to study independent and overlapping effects of prenatal nutrition and infection interventions on birth outcomes. Women were randomized to receive: 1) standard prenatal care, 2) enhanced nutrition package (ENP) (counseling, iron-folic acid [IFA], iodized salt, and balanced energy protein [BEP] supplementation), 3) enhanced infection management package (EIMP) (anti-helminthics, urinary tract infection treatment), or 4) ENP+EIMP. The current follow-up study (Longitudinal Infant Development and Growth; LIDG) will investigate biological pathways by which ENAT interventions, specifically iron, protein-energy, and inflammation, influence child neurodevelopment.
Our overarching hypotheses are that improving prenatal nutrition will improve brain structural and network development, reducing inflammation will improve white matter maturation, and the combination will have synergistic effects on child neuro-cognitive outcomes. This study will follow up to 500 ENAT children to assess neurodevelopment through 24 months of age, including neurobehavior and neural networks.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Enhanced Nutrition Package (ENP) health center + Enhanced Infection Management Package (EIMP) | – | –ENP: Health centers were strengthened to provide WHO/FMOH-recommended nutrition interventions in pregnancy. Pregnant women received a supply of adequately iodized salt for household use and iron-folate tablets from enrollment to birth. Women with undernutrition (MUAC <23 cm), also received a daily balanced energy protein supplement. EIMP: Pregnant women were screened at enrollment for bacteriuria with urine culture and antimicrobial susceptibility testing and presumptive deworming with mebendazole 500mg. Some women also received screening for chlamydia and gonorrhea and symptomatic women were tested for bacterial vaginosis and trichomonas. For women with chlamydia or gonorrhea, the participant was treated per FMOH guidelines with recommended antibiotics. STI/RTI screening was eventually discontinued due to supply shortage and the low prevalence of STI. At ANC follow-up visits, infected women were treated with antibiotics and persistent infection was retreated. |
| ENP health center, routine care infection management participant | – | –ENP: The health centers were strengthened to provide WHO/FMOH-recommended nutrition interventions in pregnancy. Pregnant women received a supply of adequately iodized salt for household use and iron-folate tablets from enrollment to birth. Women with undernutrition (MUAC <23 cm), also received a daily balanced energy protein supplement. Standard infection care: Maternal genitourinary tract infections is managed as per standard FMOH health center guidelines that utilize a syndromic management approach. |
| Routine nutrition care health center, EIMP participant | – | –Routine nutrition care: Maternal nutrition was managed as per standard FMOH health center guidelines. EIMP: Pregnant women were screened at enrollment for bacteriuria with urine culture and antimicrobial susceptibility testing and presumptive deworming with mebendazole 500mg. Some women also received screening for chlamydia and gonorrhea and symptomatic women were tested for bacterial vaginosis and trichomonas. For women with chlamydia or gonorrhea, the participant (and partner) was treated per FMOH guidelines with recommended antibiotics. STI/RTI screening was eventually discontinued due to supply shortage and the low prevalence of STI. At ANC follow-up visits, infected women were treated with antibiotics and persistent infection was retreated. |
| Routine of care nutrition and infection management | – | –Pregnant women received routine strengthened antenatal care services at the health center per FMOH guidelines. Maternal genitourinary tract infections were managed as per standard FMOH health center guidelines that utilize a syndromic management approach. |
Who may qualify
- Ages
- 9 to 27 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- The participants of this study will be recruited from 6 rural health centers (serving a ~25,000 population) involved in ENAT study in West Gojjam and South Gondar zones, Amhara, Ethiopia (Lee et al., 2022). In this infant follow-up study, up to 500 selected infants from the parent ENAT study will be followed for 24 months for general health, growth, and development. A subset of these infants (up to 480) whose mothers provided biospecimens or whose mothers had mid-upper arm circumference (MUAC) of <23 cm in the parent study will be recruited for an advanced neurodevelopmental assessment study.
Key inclusion criteria (3 listed)
- Mothers who have participated in ENAT study who consent to participate in the infant follow up study
- Intention to stay in the study catchment area
- Healthy infants without severe clinical signs or symptoms including headache, vomiting, or dizziness
Key exclusion criteria (4 listed)
- Major congenital anomalies
- Infants with severe morbidity or developmental disorder
- Neonatal encephalopathy
- Plan to move out of study catchment area
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
Child resting brain function
Time frame: 24 months
Measured by absolute power of alpha frequency band on mobile electroencephalography
12 secondary outcomes
Child resting brain function, secondary measures
Time frame: 24 months
Neural processing speed
Time frame: 24 months
Visual Attention
Time frame: 12 months
Nonverbal Visual Attention
Time frame: 12 months
Infant Neurologic Maturity
Time frame: 12 months
Child Cognitive Function
Time frame: 24 months
Child size
Time frame: 24 months
Child Size
Time frame: 24 months
Child Size
Time frame: 24 months
Child Size
Time frame: 24 months
Brain Structure
Time frame: 12 months
Child Morbidity
Time frame: 12 and 24 months
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 23 Jun 2026.
- Derived from this study: PubMed 40295129Roy Paladhi U, Workneh F, Baye E, Derebe MM, Yibeltal K, Fasil N, Driker S, Van Dyk F, I Chin T, North K, Jensen SKG, Christian P, Worku A, Berhane Y, Lee AC. Investigating biological mechanisms of adverse birth outcomes and early child development in Amhara, Ethiopia: protocol of biospecimen collection and analysis of the Enhancing Nutrition and Antenatal Infection Treatment (ENAT) randomised effectiveness study. BMJ Open. 2025 Apr 28;15(4):e098686. doi: 10.1136/bmjopen-2024-098686.
- Derived from this study: PubMed 39725450Workneh F, Chin TI, Yibeltal K, Fasil N, North K, Jensen SKG, Kidane WT, Melese M, Tsegaye S, Berhane YY, Roy Paladhi U, Abate BH, Teklehaimanot A, Melka TL, Pihl S, An WW, Van Dyk F, Mullany LC, Folger LV, Cherkerzian S, Troller-Renfree SV, Thomason ME, Andersson M, Inder T, Nelson CA, Grant PE, Christian P, Worku A, Berhane Y, Lee AC. Impact of maternal antenatal nutrition and infection treatment interventions on Longitudinal Infant Development and Growth in rural Ethiopia: protocol of the LIDG child follow-up study. BMJ Paediatr Open. 2024 Dec 24;8(1):e002840. doi: 10.1136/bmjpo-2024-002840.
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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.
Yemane Berhane principal investigator
Addis Continental Institute of Public Health
Anne CC Lee principal investigator
Warren Alpert Medical School of Brown University
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 Prenatal Exposure Delayed Effects, run by Brown University at 1 site in Ethiopia.
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 4 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 23 Jun 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 Ethiopia. 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?
Child resting brain function (time frame: 24 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06296238, which also lists 2 linked publications.
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 23 Jun 2026.