HDN - Hemolytic Disease of the NewbornNCT05617612
Neonatal Cord Blood Screening for HDN
An observational study of HDN - Hemolytic Disease of the Newborn, run by Assiut University.
Trial summary
To evaluate the diagnostic efficiency of antibodies screening in cord blood for detection of HDN. To help finding the antigen negative blood in a timely manner and reduce the morbidities and mortalities of HDN Read more about this study
- Who is it for?
- Ages 1 day to 3 days
- Conditions the study is for
- HDN - Hemolytic Disease of the Newborn
- How many people
- 400 participants
- Where
- No sites listed yet
- Study dates
- 1 Dec 2022to 1 Jan 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 1 day to 3 days
- All sexes
- Child
Study population: Full term neonates who have ABO blood group compatibility with their mothers.
Who may be able to join
- Full term neonates >/= 37 weeks.
- ABO blood compatible mother and neonate
Who cannot join
- Preterm neonates < 37 weeks.
- ABO incompatibility between mother and neonate
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Neonatal Alloantibodies in Cord Blood for Early Detection of Hemolytic Disease of Newborn
To evaluate the diagnostic efficiency of antibodies screening in cord blood for detection of HDN.
To help finding the antigen negative blood in a timely manner and reduce the morbidities and mortalities of HDN
Read the detailed description
Hemolytic disease of the newborn (HDN) refers to fetal or neonatal alloimmune hemolysis caused by red blood cell antibodies due to incompatible maternal and fetal or neonatal blood types. A French midwife first described the disorder in 1609; however, it was not until the 1950s when the underlying cause was clarified. The pathogenesis of HDN begins with the attack of fetal red blood cells (RBCs) by maternal antibodies due to incompatibility of maternal and fetal blood. Immunologically, antibody secretion initially starts with Immunoglobulin M (IgM), which cannot cross the placental barrier, but is then followed by isotype switching, which produces Immunoglobulin G (IgG) antibodies. IgG antibodies can cross the placental barrier, and they do so during the second and or subsequent pregnancies, attacking the fetal RBCs and causing hemolysis and associated complications such as Hydrops fetalis and jaundice. HDN can occur due to Rh antigens, most commonly the D antigen, and A,B and O RBCs antigens (ABO) antigens. Rh(D)-HDN has decreased since the introduction of antenatal and postpartum Rh immunoglobulin. Therefore, the prevalence of HDN, nowadays, varies according to blood type incompatibility. ABO incompatibility is the most common cause of HDN and Rh (D) antigen is the second most common cause.[8] Rh (C, c, E, e) antigen incompatibility occurs occasionally. Several other alloantibodies have also been reported to be associated with hemolytic diseases, including Kidd, Diego, Duffy, Kell and Anti-Mur. Minor blood group incompatibility due to blood groups other than Rh(D), although an uncommon cause of neonatal hyperbilirubinemia, has the potential to cause severe hyperbilirubinemia and its sequelae in infants, if left undiagnosed and untreated. Therefore, identification of at-risk cases will help clinicians to reduce neonatal morbidity and will result in better patient management
- Conditions
- HDN - Hemolytic Disease of the Newborn
- Medical subject headings
- Erythroblastosis, Fetal
What is being measured
The primary outcome is the main question the study is designed to answer.
evaluate the diagnostic efficiency of antibodies screening in cord blood for detection of HDN
Early detection of HDN through antibodies screening would help finding the antigen negative blood in a timely manner and reduce the morbidities and mortalities
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Nov 2022
- Study start1 Dec 2022 (estimated)
- Primary completion1 Dec 2023 (estimated)
- Study completion1 Jan 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for HDN - Hemolytic Disease of the NewbornStudies of the same condition, open and under way.
- More trials run by Assiut 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
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Shimaaa Abd El-Aleem, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05617612
- Sponsor's protocol ID
- HDN screening
- Status last verified
- Nov 2022
- First submitted
- 8 Nov 2022
- Last updated
- 15 Nov 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Lin M, Liu M, Zhang S, Chen C, Wang J. Different Types of Minor Blood Group Incompatibility Causing Haemolytic Disease of Neonates in one of the National Children's Medical Centre in China. J Blood Med. 2021 Jun 25;12:497-504. doi: 10.2147/JBM.S303633. eCollection 2021.
PubMed 34211305Jackson ME, Baker JM. Hemolytic Disease of the Fetus and Newborn: Historical and Current State. Clin Lab Med. 2021 Mar;41(1):133-151. doi: 10.1016/j.cll.2020.10.009. Epub 2020 Dec 24.
PubMed 33494881Gupta GK, Balbuena-Merle R, Hendrickson JE, Tormey CA. Immunohematologic aspects of alloimmunization and alloantibody detection: A focus on pregnancy and hemolytic disease of the fetus and newborn. Transfus Apher Sci. 2020 Oct;59(5):102946. doi: 10.1016/j.transci.2020.102946. Epub 2020 Sep 16.
PubMed 32962917Alaqeel AA. Hyporegenerative anemia and other complications of rhesus hemolytic disease: to treat or not to treat is the question. Pan Afr Med J. 2019 Mar 14;32:120. doi: 10.11604/pamj.2019.32.120.17757. eCollection 2019.
PubMed 31223410Tewari VV, Kumar A, Singhal A, Pillai N, Prakash A, Varghese J, Kannan V. Evaluation of Rh-Hemolytic Disease in Neonates and Management with Early Intensive Phototherapy in the Neonatal Intensive Care Unit. J Trop Pediatr. 2020 Feb 1;66(1):75-84. doi: 10.1093/tropej/fmz033.
PubMed 31199484
Study at a glance
From the registry record, last updated by the sponsor on 15 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neonatal Alloantibodies in Cord Blood for Early Detection of Hemolytic Disease of Newborn
- ClinicalTrials.gov ID
- NCT05617612
- Acronym / sponsor ID
- HDN screening
- Conditions
- HDN - Hemolytic Disease of the Newborn
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Dec 2022 (estimated)
- Primary completion
- 1 Dec 2023 (estimated)
- Study completion
- 1 Jan 2024 (estimated)
- First posted
- 15 Nov 2022 (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.
To evaluate the diagnostic efficiency of antibodies screening in cord blood for detection of HDN.
To help finding the antigen negative blood in a timely manner and reduce the morbidities and mortalities of HDN
Detailed description
Hemolytic disease of the newborn (HDN) refers to fetal or neonatal alloimmune hemolysis caused by red blood cell antibodies due to incompatible maternal and fetal or neonatal blood types. A French midwife first described the disorder in 1609; however, it was not until the 1950s when the underlying cause was clarified. The pathogenesis of HDN begins with the attack of fetal red blood cells (RBCs) by maternal antibodies due to incompatibility of maternal and fetal blood. Immunologically, antibody secretion initially starts with Immunoglobulin M (IgM), which cannot cross the placental barrier, but is then followed by isotype switching, which produces Immunoglobulin G (IgG) antibodies. IgG antibodies can cross the placental barrier, and they do so during the second and or subsequent pregnancies, attacking the fetal RBCs and causing hemolysis and associated complications such as Hydrops fetalis and jaundice. HDN can occur due to Rh antigens, most commonly the D antigen, and A,B and O RBCs antigens (ABO) antigens. Rh(D)-HDN has decreased since the introduction of antenatal and postpartum Rh immunoglobulin. Therefore, the prevalence of HDN, nowadays, varies according to blood type incompatibility. ABO incompatibility is the most common cause of HDN and Rh (D) antigen is the second most common cause.[8] Rh (C, c, E, e) antigen incompatibility occurs occasionally. Several other alloantibodies have also been reported to be associated with hemolytic diseases, including Kidd, Diego, Duffy, Kell and Anti-Mur. Minor blood group incompatibility due to blood groups other than Rh(D), although an uncommon cause of neonatal hyperbilirubinemia, has the potential to cause severe hyperbilirubinemia and its sequelae in infants, if left undiagnosed and untreated. Therefore, identification of at-risk cases will help clinicians to reduce neonatal morbidity and will result in better patient management
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 1 day to 3 days
- Sex
- All
- Age groups
- Child
- Study population
- Full term neonates who have ABO blood group compatibility with their mothers.
Key inclusion criteria (2 listed)
- Full term neonates >/= 37 weeks.
- ABO blood compatible mother and neonate
Key exclusion criteria (2 listed)
- Preterm neonates < 37 weeks.
- ABO incompatibility between mother and neonate
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
evaluate the diagnostic efficiency of antibodies screening in cord blood for detection of HDN
Time frame: Baseline
Early detection of HDN through antibodies screening would help finding the antigen negative blood in a timely manner and reduce the morbidities and mortalities
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Nov 2022.
- Background: PubMed 34211305Lin M, Liu M, Zhang S, Chen C, Wang J. Different Types of Minor Blood Group Incompatibility Causing Haemolytic Disease of Neonates in one of the National Children's Medical Centre in China. J Blood Med. 2021 Jun 25;12:497-504. doi: 10.2147/JBM.S303633. eCollection 2021.
- Background: PubMed 33494881Jackson ME, Baker JM. Hemolytic Disease of the Fetus and Newborn: Historical and Current State. Clin Lab Med. 2021 Mar;41(1):133-151. doi: 10.1016/j.cll.2020.10.009. Epub 2020 Dec 24.
- Background: PubMed 32962917Gupta GK, Balbuena-Merle R, Hendrickson JE, Tormey CA. Immunohematologic aspects of alloimmunization and alloantibody detection: A focus on pregnancy and hemolytic disease of the fetus and newborn. Transfus Apher Sci. 2020 Oct;59(5):102946. doi: 10.1016/j.transci.2020.102946. Epub 2020 Sep 16.
- Background: PubMed 31223410Alaqeel AA. Hyporegenerative anemia and other complications of rhesus hemolytic disease: to treat or not to treat is the question. Pan Afr Med J. 2019 Mar 14;32:120. doi: 10.11604/pamj.2019.32.120.17757. eCollection 2019.
- Background: PubMed 31199484Tewari VV, Kumar A, Singhal A, Pillai N, Prakash A, Varghese J, Kannan V. Evaluation of Rh-Hemolytic Disease in Neonates and Management with Early Intensive Phototherapy in the Neonatal Intensive Care Unit. J Trop Pediatr. 2020 Feb 1;66(1):75-84. doi: 10.1093/tropej/fmz033.
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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.
Questions about this trial
What is this clinical trial studying?
An observational study of HDN - Hemolytic Disease of the Newborn, run by Assiut University.
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 2 inclusion and 2 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: status not confirmed, as of the sponsor's last update on 15 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Shimaa AE Ahmed, MD (01065952778, shimaaabdalaleem@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
evaluate the diagnostic efficiency of antibodies screening in cord blood for detection of HDN (time frame: Baseline). 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 NCT05617612, which also lists 5 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 15 Nov 2022.