PrematurityPhase 1NCT01121328
Autologous Umbilical Cord Blood Transfusion for Preterm Neonates
A Phase 1 study testing Autologous cord blood transfusion for preterm neonates and Autologous cord blood transfusion in people with Prematurity and Respiratory Distress Syndrome, run by Sahar M.A. Hassanein, MD at 1 site in Egypt.
Trial summary
This is a pilot study to test feasibility of collection, preparation and infusion of a baby's own (autologous) umbilical cord blood in the first 14 days after birth if the baby is born premature <35 weeks of gestation. Read more about this study
- Who is it for?
- Ages 1 day to 30 days
- Conditions the study is for
- Prematurity, Respiratory Distress Syndrome, Anemia of Prematurity
- What is being tested?
- Autologous cord blood transfusion for preterm neonates and Autologous cord blood transfusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteEgypt
- Study dates
- Jul 2011to Sep 2014
- Phase
- Phase 1
- 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 30 days
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Preterm neonates less than 34 weeks of gestation.
- Low birth weight less than 1500 grams
Who cannot join
- Congenital malformations.
- Suspected inborn error of metabolism.
- Suspected inherited neurologic disease.
Trial locations and contacts
1 site in 1 country.
Egypt1 site
Children's Hospital, Faculty of Medicine, Ain Shams University
Cairo, 11381
About this study
Official title: Autologous Umbilical Cord Blood Transfusion for Preterm and Low Birth Weight Neonates: A Pilot Feasibility Study
This is a pilot study to test feasibility of collection, preparation and infusion of a baby's own (autologous) umbilical cord blood in the first 14 days after birth if the baby is born premature <35 weeks of gestation.
Read the detailed description
In Egypt, 12-15.8% of live neonates are low birth weight and it is estimated that about one third of such infants are preterm [1] (UNICEF, 2001). In a study that Campbell et al. (2004) conducted in Egypt, the neonatal mortality rate was estimated to be 25 per 1000 live births. prematurity was considered the main cause of neonatal deaths (39%), followed by asphyxia (18%), infection (7%), especially in the late neonatal period, and congenital malformations (6%). A substantial proportion (29%) could not be classified [2]. In developing countries, prematurity was the main cause of early neonatal deaths (62%)[3] Autologous cord blood transfusion will be safe, and cheap. The preterm neonates need transfusion of whole blood or any of its components at a time during NICU admission.
- Conditions
- Prematurity, Respiratory Distress Syndrome, Anemia of Prematurity, Intraventricular Hemorrhage
- Being tested
- Autologous cord blood transfusion for preterm neonates, Autologous cord blood transfusion
- Keywords
- Preterm neonates., Autologous cord blood transfusion.
- Medical subject headings
- Premature Birth, Respiratory Distress Syndrome, Anemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Autologous cord blood transfusion for preterm neonatesBiological
Also called Transfusion blood bag collection.
Cord blood collection after delivery of the baby. Preservation of blood in blood bank. Transfusion of blood within the first 14 postnatal days to maintain Hb level above 10gm%.
Autologous cord blood transfusionBiological
Also called Cord blood transfusion for preterm neonates
After delivery of the baby and before placental delivery in vaginal delivery. After delivery of the baby the placental will be taken out in cesarean section. sterilization of the umbilical cord will be done. Puncture of the umbilical cord vein with the needle of blood transfusion bag will be done.
Blood will be kept in the blood bank. Blood grouping, haematocrit and CBC will be done for the cord blood.Maternal sample will be analysed simultaneously.
Mononuclear layer will be separated within 6 hours and transfused to the preterm neonate immediately.
RBCs will be separated and kept till need (Hb less than 10 gm%).
| Study group | Role | What they receive |
|---|---|---|
| Autologous cord blood transfusion | Experimental | Collected cord blood at birth will be transfused for the preterm neonate Receives: Biological: Autologous cord blood transfusion for preterm neonates; Biological: Autologous cord blood transfusion |
What is being measured
The primary outcome is the main question the study is designed to answer.
Duration of mechanical ventilation
-No need for mechanical ventilation.
Measured: 30 days
Secondary outcomes (1)
Survival
- Survival until 12 months of age.
- Improved physical growth and weight gain.
- Neurodevelopmental outcome at 6, 12 and 18 months of age.
Measured: 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 May 2010 (estimated)
- Study startJul 2011
- Primary completionMar 2014
- Study completionSep 2014
Why it stopped: No recruitment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PrematurityStudies 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
- Interventional
- Phase
- Phase 1
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sahar M.A. Hassanein, MD
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Sahar M.A. Hassanein, MD, Ain Shams University
- Investigators
- Prof. Sahar MA Hassanein, MD, Principal investigator, Children's Hospital, Faculty of Medicine, Ain Shams University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01121328
- Sponsor's protocol ID
- IRB#1
- Status last verified
- Feb 2019
- First submitted
- 3 May 2010
- Last updated
- 12 Feb 2019
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Autologous Umbilical Cord Blood Transfusion for Preterm and Low Birth Weight Neonates: A Pilot Feasibility Study
- ClinicalTrials.gov ID
- NCT01121328
- Acronym / sponsor ID
- IRB#1
- Conditions
- Prematurity, Respiratory Distress Syndrome, Anemia of Prematurity, Intraventricular Hemorrhage
- Keywords
- Preterm neonates., Autologous cord blood transfusion.
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: No recruitment
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Sahar M.A. Hassanein, MDUniversity, hospital or other
- Study start
- Jul 2011
- Primary completion
- Mar 2014 (actual)
- Study completion
- Sep 2014 (actual)
- First posted
- 12 May 2010 (estimated)
- 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.
This is a pilot study to test feasibility of collection, preparation and infusion of a baby's own (autologous) umbilical cord blood in the first 14 days after birth if the baby is born premature <35 weeks of gestation.
Detailed description
In Egypt, 12-15.8% of live neonates are low birth weight and it is estimated that about one third of such infants are preterm [1] (UNICEF, 2001). In a study that Campbell et al. (2004) conducted in Egypt, the neonatal mortality rate was estimated to be 25 per 1000 live births. prematurity was considered the main cause of neonatal deaths (39%), followed by asphyxia (18%), infection (7%), especially in the late neonatal period, and congenital malformations (6%). A substantial proportion (29%) could not be classified [2]. In developing countries, prematurity was the main cause of early neonatal deaths (62%)[3] Autologous cord blood transfusion will be safe, and cheap. The preterm neonates need transfusion of whole blood or any of its components at a time during NICU admission.
Study design
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Autologous cord blood transfusion | Experimental | Biological: Autologous cord blood transfusion for preterm neonates, Biological: Autologous cord blood transfusionCollected cord blood at birth will be transfused for the preterm neonate |
Who may qualify
- Ages
- 1 day to 30 days
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Preterm neonates less than 34 weeks of gestation.
- Low birth weight less than 1500 grams
Key exclusion criteria (3 listed)
- Congenital malformations.
- Suspected inborn error of metabolism.
- Suspected inherited neurologic disease.
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 |
|---|---|---|
| Autologous cord blood transfusion for preterm neonatesAlso: Transfusion blood bag collection.Cord blood collection after delivery of the baby. Preservation of blood in blood bank. Transfusion of blood within the first 14 postnatal days to maintain Hb level above 10gm%. | Biological | Autologous cord blood transfusion |
| Autologous cord blood transfusionAlso: Cord blood transfusion for preterm neonatesAfter delivery of the baby and before placental delivery in vaginal delivery. After delivery of the baby the placental will be taken out in cesarean section. sterilization of the umbilical cord will be done. Puncture of the umbilical cord vein with the needle of blood transfusion bag will be done. Blood will be kept in the blood bank. Blood grouping, haematocrit and CBC will be done for the cord blood.Maternal sample will be analysed simultaneously. Mononuclear layer will be separated within 6 hours and transfused to the preterm neonate immediately. RBCs will be separated and kept till need (Hb less than 10 gm%). | Biological | Autologous cord blood transfusion |
Primary outcome
Duration of mechanical ventilation
Time frame: 30 days
-No need for mechanical ventilation.
1 secondary outcome
Survival
Time frame: 18 months
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Feb 2019.
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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.
Prof. Sahar MA Hassanein, MD principal investigator
Children's Hospital, Faculty of Medicine, Ain Shams University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Autologous cord blood transfusion for preterm neonates and Autologous cord blood transfusion in people with Prematurity and Respiratory Distress Syndrome, run by Sahar M.A. Hassanein, MD at 1 site in Egypt.
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 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: withdrawn, as of the sponsor's last update on 12 Feb 2019. 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 Egypt. 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.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
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?
Duration of mechanical ventilation (time frame: 30 days). 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 12 Feb 2019.