Pregnancy RelatedNEWbornIMMPACTNCT07033663
Impact of In Utero Exposure to Immunomodulatory Drugs on Neonatal Immune System Development
An observational study of Pregnancy Related and Immune-mediated Diseases, run by Fundació Sant Joan de Déu at 3 sites in Spain.
Trial summary
What is this project about? This project aims to better understand how the immune system develops in babies whose mothers received immunomodulatory treatments during pregnancy. These treatments are necessary for women with autoimmune, inflammatory, allergic, or cancer-related diseases who cannot stop their medication… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Pregnancy Related, Immune-mediated Diseases
- What is being tested?
- Monoclonal antibody
- How many people
- 90 participants
- Where
- 3 sitesSpain
- Study dates
- 1 Jun 2018to 1 May 2028
- How long will I take part?
- 12 Months
- 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
- No healthy volunteers
- Child, Adult, Older adult
Study population: Pregnant women with immune-mediated inflammatory or oncologic diseases. 90 mother-child pairs: 15 per each of the 6 disease groups: rheumatology, neuroimmunology, dermatology, inflammatory bowel disease, allergy, and oncology.
Who may be able to join
- Pregnant women with immune-mediated inflammatory or oncologic diseases, categorized into:
- High-exposed group: monoclonal treatment throughout pregnancy.
- Low-exposed group: monoclonal treatment limited to the first/second trimester.
- Non-exposed group: No monoclonal exposure or treatment with non-placental-crossing biologics, serving as a control to distinguish immunological changes attributable to maternal disease.
- -
Who cannot join
None listed.
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Spain3 sites, 3 recruiting
- Recruiting
Hospital Clínic de Barcelona
Barcelona, 08035
Nuria Baños, +34 936009733, frecerca.aro@sjd.es
- Recruiting
Hospital Universitari Vall d'Hebrón
Barcelona, 08035
Paula Tagliani, +34 936009733, frecerca.aro@sjd.es
- Recruiting
Hospital Sant Joan de Déu
Esplugues de Llobregat, Barcelona, 08950
Laia Alsina Manrique Principal Investigator, +34 936009733, frecerca.aro@sjd.es
About this study
Official title: Study of the Impact of Intrauterine Exposure to Immunomodulatory Drugs on the Development of the Immune System of Children Born to Mothers With Chronic Inflammatory or Oncologic Diseases: The NEWborn-IMM-PACT Study
What is this project about? This project aims to better understand how the immune system develops in babies whose mothers received immunomodulatory treatments during pregnancy. These treatments are necessary for women with autoimmune, inflammatory, allergic, or cancer-related diseases who cannot stop their medication while pregnant.
Why is it important? Although these treatments help keep the mother and baby healthy, some medications can cross the placenta and affect the baby's immune system. Since pregnant women are usually not included in clinical trials, the investigators still don't know exactly how these drugs might influence the baby's immune development.
Read more
How will the investigators do it? The investigators will follow a group of pregnant women receiving these treatments and monitor their babies at birth, and at 3, 6, and 12 months. The study will take place in three leading hospitals in Spain: Hospital Sant Joan de Déu, Hospital Clínic, and Vall d'Hebron. The investigators will also use organoid models in the lab to better understand how these drugs affect fetal development.
Who will benefit? This study will help parents concerned about the impact of treatments during pregnancy on their child's health. It will also give doctors the evidence they need to make safer treatment decisions, and support the creation of new clinical guidelines to protect both mothers and babies.
Read the detailed description
The use of immunomodulatory drugs (IMD) in chronic inflammatory or oncologic diseases is increasingly widespread in pregnant women who have gestational desire and need to keep their disease under control for the safety of pregnancy. General objective: analyze the safety of IMD exposure during pregnancy used in clinical practice on the development of the newborn immune system. Specific objectives: 1) To evaluate lymphoid organogenesis, including regulatory T/B populations, and the direct effect on the drug target immune pathway, in cord and peripheral blood of newborns exposed in utero to biologic immunomodulators (bIMD, monoclonals and fusion protein); 2) To evaluate the epigenetic fingerprint in cord and peripheral blood of newborns exposed in utero to bIMD; 3) To develop an in vitro model (organoid-platform) to study the impact of IMD and maternal disease in the fetal period. 4) To develop a guide of specific recommendations, which includes the perspective of the newborn. Methods: Observational multicenter prospective cohort study of infants exposed to bIMD during pregnancy, born to mothers with chronic inflammatory or oncologic diseases. Clinical and analytical follow-up, from birth, at 3,6 and 12 months. Clinical: general health status, data on infections or autoimmune or allergic events. Analytical: serum levels of bIMD, maturation and function of T and B extended lymphocyte populations, integrity of the bIMD target pathway, study of epigenetic changes. The results will be compared with a control population. In vitro study: organoid-based models obtained from hiPSCs differentiated towards hematopoietic components; B-cell maturation will be evaluated after different IMD exposure. The investigators expect to: 1) surmount the knowledge gap on the impact of in utero IMD exposure, to define the newborn infectious risk, of autoimmunity and/or allergy, and 2) to be create and disseminate protocols of follow-up specific to them.
- Conditions
- Pregnancy Related, Immune-mediated Diseases
- Being tested
- Monoclonal antibody
- Keywords
- monoclonal antibodies, pregnancy, immunomodulators
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Monoclonal antibodyDrug
Also called non-intervention. Drug used in clinical practice
non-intervention. Drug used in clinical practice as per practitioner decision
| Study group | Role | What they receive |
|---|---|---|
| Pregnant women with chronic inflammatory and/or oncological diseases exposed to mAb during pregnancy | Study Population:
Inclusion criteria: Pregnant women with immune-mediated inflammatory or oncologic diseases, categorized into:
1. High-exposed group: IMD treatment throughout pregnancy.
2. Low-exposed group: IMD treatment limited to the first/second trimester.
3. Non-exposed group: No IMD exposure or treatment with non-placental-crossing biologics, serving as a control to distinguish immunological changes attributable to maternal disease.
Newborns and an age- and sex-matched healthy control group (0-12 months) will be included.
Exclusion criteria for mother and child: lack of signed informed consent, primary immunodeficiencies, active infection at the time of sampling or significant comorbidities. Receives: Drug: Monoclonal antibody |
What is being measured
The primary outcome is the main question the study is designed to answer.
Growth
Growth will be measured with OMS scale. The World Health Organization (WHO) Child Growth Standards (0-5 years) and WHO Growth Reference (5-19 years) use Z-scores to assess growth, typically ranging from -6 to +6, with most values between -3 and +3. Higher scores indicate greater body size, which can mean better growth (e.g., height-for-age) or a worse outcome (e.g., overweight or obesity in BMI-for-age), depending on the growth index used.
Measured: first 12 months of age
Neurodevelopment
Neurodevelopment will be measured with Haizea-Llevant scale. The Haizea-Llevant scale is a standardized tool used in Spain to assess neurodevelopment in children aged 0 to 5 years, based on the Denver Developmental Screening Test. It evaluates development across four domains, and scores are reported as age of acquisition of milestones or percentile ranges, with higher scores indicating better neurodevelopmental outcomes; there is no fixed minimum or maximum, as it depends on age-specific milestones. A child scoring below the 3rd percentile in one or more areas may indicate developmental delay and require further evaluation.
Measured: first 12 months of age
Infection history
Number and type of infections will be recorded
Measured: first 12 months of age
Vaccine response
IgG responses to tetanus, diphtheria and pneumococcus
Measured: first 12 months of age
Hypersensitivity
Atopy, food allergy will be recorded. Atopy and food allergy will be assessed based on clinical history obtained through structured clinical interview and findings from physical examination, following standard diagnostic criteria. No specific questionnaire or scale will be used, as data will be collected descriptively during routine clinical evaluation.
Measured: first 12 months of age
Immune Profiling in neonatal samples: Spectral flow cytometry
Investigators will perform a comprehensive immune cell phenotype (T/B/NK cells, T and B regulatory subsets) from cord and peripheral blood samples and evaluate de % of each cell type to be compared to age-matched healthy controls reference values
Measured: first 12 months of age
Immune Profiling in neonatal samples: T cell function
Investigators will evaluate T cell response to stimulants (PHA, PWM, ConA) and calculate the proliferation capacity in % compared to age-matched healthy controls.
Measured: first 12 months of age
Immune Profiling in neonatal samples: B cell function
Investigators will evaluate B cell function by performing Plasmablast differentiation and measuring immunoglobulin production (IgG, IgA, IgM).
Measured: first 12 months of age
Immune Profiling in neonatal samples: Cytokine profiling
Investigators will perform a 92-cytokine panel (Olink platform, advanced PCR technology) to measure different cytokine abundance in serum samples
Measured: first 12 months of age
Immune Profiling in neonatal samples: IMD Monitoring
Investigators will perform an ELISA-based maternal/neonatal IMD (immunomodulatory drug) concentration analysis to measure drug levels in serum samples
Measured: first 12 months of age
Immune Profiling in neonatal samples: Vaccine responses
Investigators will measure Antibody titers for tetanus, diphtheria, pneumococcus using commercial kits. à afegeix (IgG) despres de antibody titers.
Measured: first 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 posted24 Jun 2025
- Study start1 Jun 2018
- Primary completion1 Dec 2027 (estimated)
- Study completion1 May 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pregnancy RelatedStudies of the same condition, open and under way.
- 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
- 90 participants (estimated)
- Target duration
- 12 Months
Sponsor and investigators
- Lead sponsor
- Fundació Sant Joan de Déu
- Sponsor type
- University, hospital or other
- Collaborators
- Hospital Clinic of Barcelona, Hospital Vall d'Hebron
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07033663
- Sponsor's protocol ID
- NEWborn-IMM-PACT
- Acronym
- NEWbornIMMPACT
- Status last verified
- May 2025
- First submitted
- 28 May 2025
- Last updated
- 15 Aug 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of the Impact of Intrauterine Exposure to Immunomodulatory Drugs on the Development of the Immune System of Children Born to Mothers With Chronic Inflammatory or Oncologic Diseases: The NEWborn-IMM-PACT Study
- ClinicalTrials.gov ID
- NCT07033663
- Acronym / sponsor ID
- NEWbornIMMPACT / NEWborn-IMM-PACT
- Conditions
- Pregnancy Related, Immune-mediated Diseases
- Keywords
- monoclonal antibodies, pregnancy, immunomodulators
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Fundació Sant Joan de DéuUniversity, hospital or other
- Collaborators
- Hospital Clinic of Barcelona, Hospital Vall d'Hebron
- Study start
- 1 Jun 2018 (actual)
- Primary completion
- 1 Dec 2027 (estimated)
- Study completion
- 1 May 2028 (estimated)
- First posted
- 24 Jun 2025 (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.
What is this project about? This project aims to better understand how the immune system develops in babies whose mothers received immunomodulatory treatments during pregnancy. These treatments are necessary for women with autoimmune, inflammatory, allergic, or cancer-related diseases who cannot stop their medication while pregnant.
Why is it important? Although these treatments help keep the mother and baby healthy, some medications can cross the placenta and affect the baby's immune system. Since pregnant women are usually not included in clinical trials, the investigators still don't know exactly how these drugs might influence the baby's immune development.
How will the investigators do it? The investigators will follow a group of pregnant women receiving these treatments and monitor their babies at birth, and at 3, 6, and 12 months. The study will take place in three leading hospitals in Spain: Hospital Sant Joan de Déu, Hospital Clínic, and Vall d'Hebron. The investigators will also use organoid models in the lab to better understand how these drugs affect fetal development.
Who will benefit? This study will help parents concerned about the impact of treatments during pregnancy on their child's health. It will also give doctors the evidence they need to make safer treatment decisions, and support the creation of new clinical guidelines to protect both mothers and babies.
Detailed description
The use of immunomodulatory drugs (IMD) in chronic inflammatory or oncologic diseases is increasingly widespread in pregnant women who have gestational desire and need to keep their disease under control for the safety of pregnancy. General objective: analyze the safety of IMD exposure during pregnancy used in clinical practice on the development of the newborn immune system. Specific objectives: 1) To evaluate lymphoid organogenesis, including regulatory T/B populations, and the direct effect on the drug target immune pathway, in cord and peripheral blood of newborns exposed in utero to biologic immunomodulators (bIMD, monoclonals and fusion protein); 2) To evaluate the epigenetic fingerprint in cord and peripheral blood of newborns exposed in utero to bIMD; 3) To develop an in vitro model (organoid-platform) to study the impact of IMD and maternal disease in the fetal period. 4) To develop a guide of specific recommendations, which includes the perspective of the newborn. Methods: Observational multicenter prospective cohort study of infants exposed to bIMD during pregnancy, born to mothers with chronic inflammatory or oncologic diseases. Clinical and analytical follow-up, from birth, at 3,6 and 12 months. Clinical: general health status, data on infections or autoimmune or allergic events. Analytical: serum levels of bIMD, maturation and function of T and B extended lymphocyte populations, integrity of the bIMD target pathway, study of epigenetic changes. The results will be compared with a control population. In vitro study: organoid-based models obtained from hiPSCs differentiated towards hematopoietic components; B-cell maturation will be evaluated after different IMD exposure. The investigators expect to: 1) surmount the knowledge gap on the impact of in utero IMD exposure, to define the newborn infectious risk, of autoimmunity and/or allergy, and 2) to be create and disseminate protocols of follow-up specific to them.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 12 Months
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Pregnant women with chronic inflammatory and/or oncological diseases exposed to mAb during pregnancy | – | Drug: Monoclonal antibodyStudy Population: Inclusion criteria: Pregnant women with immune-mediated inflammatory or oncologic diseases, categorized into: 1. High-exposed group: IMD treatment throughout pregnancy. 2. Low-exposed group: IMD treatment limited to the first/second trimester. 3. Non-exposed group: No IMD exposure or treatment with non-placental-crossing biologics, serving as a control to distinguish immunological changes attributable to maternal disease. Newborns and an age- and sex-matched healthy control group (0-12 months) will be included. Exclusion criteria for mother and child: lack of signed informed consent, primary immunodeficiencies, active infection at the time of sampling or significant comorbidities. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Pregnant women with immune-mediated inflammatory or oncologic diseases. 90 mother-child pairs: 15 per each of the 6 disease groups: rheumatology, neuroimmunology, dermatology, inflammatory bowel disease, allergy, and oncology.
Key inclusion criteria (5 listed)
- High-exposed group: monoclonal treatment throughout pregnancy.
- Low-exposed group: monoclonal treatment limited to the first/second trimester.
- Non-exposed group: No monoclonal exposure or treatment with non-placental-crossing biologics, serving as a control to distinguish immunological changes attributable to maternal disease.
- -
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| Monoclonal antibodyAlso: non-intervention. Drug used in clinical practicenon-intervention. Drug used in clinical practice as per practitioner decision | Drug | Pregnant women with chronic inflammatory and/or oncological diseases exposed to mAb during pregnancy |
Primary outcome
Growth
Time frame: first 12 months of age
Growth will be measured with OMS scale. The World Health Organization (WHO) Child Growth Standards (0-5 years) and WHO Growth Reference (5-19 years) use Z-scores to assess growth, typically ranging from -6 to +6, with most values between -3 and +3. Higher scores indicate greater body size, which can mean better growth (e.g., height-for-age) or a worse outcome (e.g., overweight or obesity in BMI-for-age), depending on the growth index used.
Neurodevelopment
Time frame: first 12 months of age
Neurodevelopment will be measured with Haizea-Llevant scale. The Haizea-Llevant scale is a standardized tool used in Spain to assess neurodevelopment in children aged 0 to 5 years, based on the Denver Developmental Screening Test. It evaluates development across four domains, and scores are reported as age of acquisition of milestones or percentile ranges, with higher scores indicating better neurodevelopmental outcomes; there is no fixed minimum or maximum, as it depends on age-specific milestones. A child scoring below the 3rd percentile in one or more areas may indicate developmental delay and require further evaluation.
Infection history
Time frame: first 12 months of age
Number and type of infections will be recorded
Vaccine response
Time frame: first 12 months of age
IgG responses to tetanus, diphtheria and pneumococcus
Hypersensitivity
Time frame: first 12 months of age
Atopy, food allergy will be recorded. Atopy and food allergy will be assessed based on clinical history obtained through structured clinical interview and findings from physical examination, following standard diagnostic criteria. No specific questionnaire or scale will be used, as data will be collected descriptively during routine clinical evaluation.
Immune Profiling in neonatal samples: Spectral flow cytometry
Time frame: first 12 months of age
Investigators will perform a comprehensive immune cell phenotype (T/B/NK cells, T and B regulatory subsets) from cord and peripheral blood samples and evaluate de % of each cell type to be compared to age-matched healthy controls reference values
Immune Profiling in neonatal samples: T cell function
Time frame: first 12 months of age
Investigators will evaluate T cell response to stimulants (PHA, PWM, ConA) and calculate the proliferation capacity in % compared to age-matched healthy controls.
Immune Profiling in neonatal samples: B cell function
Time frame: first 12 months of age
Investigators will evaluate B cell function by performing Plasmablast differentiation and measuring immunoglobulin production (IgG, IgA, IgM).
Immune Profiling in neonatal samples: Cytokine profiling
Time frame: first 12 months of age
Investigators will perform a 92-cytokine panel (Olink platform, advanced PCR technology) to measure different cytokine abundance in serum samples
Immune Profiling in neonatal samples: IMD Monitoring
Time frame: first 12 months of age
Investigators will perform an ELISA-based maternal/neonatal IMD (immunomodulatory drug) concentration analysis to measure drug levels in serum samples
Immune Profiling in neonatal samples: Vaccine responses
Time frame: first 12 months of age
Investigators will measure Antibody titers for tetanus, diphtheria, pneumococcus using commercial kits. à afegeix (IgG) despres de antibody titers.
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 15 Aug 2025.
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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.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pregnancy Related and Immune-mediated Diseases, run by Fundació Sant Joan de Déu at 3 sites in Spain.
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 5 inclusion and 0 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: looking for participants now, as of the sponsor's last update on 15 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Spain. 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?
Contact Laia Alsina, MD, PhD (+34 936009733, frecerca.aro@sjd.es), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Growth (time frame: first 12 months of age). The study lists 11 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 15 Aug 2025.