Preterm InfantNCT03731546
Effect of Delayed Cord Clamping in Preterm Neonates With Placental Insufficiency
A study testing Delayed cord clamping in people with Preterm Infant and Placental Insufficiency, run by Mansoura University Children Hospital at 1 site in Egypt.
Trial summary
To investigate the effect of delayed cord clamping (DCC) on hematopoietic progenitor cells (HPCs), hematological parameters including haemoglobin concentration and hematocrit value in premature infants (34 weeks gestational age or less) with placental insufficiency.We hypothesized that preterm infants with placental… Read more about this study
- Who is it for?
- Ages 0 minutes to 1 minute
- Conditions the study is for
- Preterm Infant, Placental Insufficiency, Placental Transfusion
- What is being tested?
- Delayed cord clamping
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Sep 2017to 1 Mar 2019
- Phase
- Interventional
- 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 0 minutes to 1 minute
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- preterm neonates < 34 weeks gestational age
Who cannot join
- Vaginal bleeding due to placental abruption or tears Multiple pregnancies Suspected major fetal anomalies Suspected chromosomal aberration Maternal drug abuse Hydrops fetalis preterm who needed major resuscitative measures
Trial locations and contacts
1 site in 1 country.
About this study
To investigate the effect of delayed cord clamping (DCC) on hematopoietic progenitor cells (HPCs), hematological parameters including haemoglobin concentration and hematocrit value in premature infants (34 weeks gestational age or less) with placental insufficiency.We hypothesized that preterm infants with placental insufficiency underwent DDC could have better hematologic parameters and hematopoietic progenitor cells compared to immediate cord clamping.
Read the detailed description
- A prospective randomized controlled study will be performed on preterm infants 34 weeks gestational age or less with placental insufficiency, and those without placental insufficiency where DCC will be performed in both groups. A third group of preterm with placental insufficiency and immediate cord clamping will be performed as a control.
- Being tested
- Delayed cord clamping
- Keywords
- Delayed cord clamping, Preterm Infant, Placental Insufficiency, Intrauterine growth restriction
- Medical subject headings
- Premature Birth, Placental Insufficiency, Fetofetal Transfusion, Fetal Growth Retardation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Delayed cord clampingProcedure or surgery
Cord clamping 60 seconds after delivery of fetus in preterm infants
| Study group | Role | What they receive |
|---|---|---|
| Group A | No intervention | Placental insufficiency and ICC : Immediate cord clamping after delivery of the fetus in preterm infants with placental insufficiency |
| Group B | Active comparator | Placental insufficiency and DCC: Cord clamping 60 seconds after delivery of fetus in preterm infants with placental insufficiency Receives: Procedure: Delayed cord clamping |
| Group C | Active comparator | Normal placenta with DCC:Cord clamping 60 seconds after delivery of fetus in preterm infants without placental insufficiency Receives: Procedure: Delayed cord clamping |
What is being measured
The primary outcome is the main question the study is designed to answer.
Peripheral venous CD34 at admission
One milliliter of fetal blood will be taken from peripheral venous blood in the first 30 minutes of life and CD34 will be assessed by flow cytometry.
Measured: first 24 hours of infants' life
Secondary outcomes (16)
Admission hemoglobin
One milliliter of neonatal blood will be taken from peripheral venous blood in the first 24 hours of life.
Measured: first 24 hours of infants' life
Hemoglobin at 2 months
One milliliter of neonatal blood will be taken from peripheral venous blood at 2 months of life.
Measured: 2 months of infants' life
Admission platelets
One milliliter of neonatal blood will be taken from peripheral venous blood in the first 24 hours of life.
Measured: first 24 hours of infants' life
Admission WBCs
One milliliter of neonatal blood will be taken from peripheral venous blood in the first 24
Measured: first 24 hours of infants' life
Phototherapy requirements
Measured: first 28 days of life
Polycythemia
Measured: first 28 days of life
Culture proven sepsis
Measured: first 28 days of life
Necrotizing enterocolitis
Measured: first 28 days of life
Intraventricular hemorrhage
Measured: first 28 days of life
Bronchopulmonary dysplasia
Measured: first 70 days of life
Need for nasal CPAP
Measured: first 28 days of life
Need for mechanical ventilation
Measured: first 28 days of life
Duration of oxygen therapy
Measured: first 28 days of life
Need for inotropes
Measured: first 28 days of life
Retinopathy of prematurity
Measured: first 28 days of life
Need for packed RBCs transfusion
Measured: first 28 days of life
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Nov 2018
- Study start1 Sep 2017
- Primary completion1 Mar 2019
- Study completion1 Mar 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Preterm InfantStudies 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 N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mansoura University Children Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nehad Nasef, Mansoura University Children Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03731546
- Sponsor's protocol ID
- MS/17.04.15
- Status last verified
- May 2022
- First submitted
- 3 Nov 2018
- Last updated
- 17 May 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Gokmen Z, Ozkiraz S, Tarcan A, Kozanoglu I, Ozcimen EE, Ozbek N. Effects of delayed umbilical cord clamping on peripheral blood hematopoietic stem cells in premature neonates. J Perinat Med. 2011 May;39(3):323-9. doi: 10.1515/jpm.2011.021. Epub 2011 Mar 11.
PubMed 21391876Committee on Obstetric Practice, American College of Obstetricians and Gynecologists. Committee Opinion No.543: Timing of umbilical cord clamping after birth. Obstet Gynecol. 2012 Dec;120(6):1522-6. doi: 10.1097/01.AOG.0000423817.47165.48.
PubMed 23168790Yunis M, Nour I, Gibreel A, Darwish M, Sarhan M, Shouman B, Nasef N. Effect of delayed cord clamping on stem cell transfusion and hematological parameters in preterm infants with placental insufficiency: a pilot randomized trial. Eur J Pediatr. 2021 Jan;180(1):157-166. doi: 10.1007/s00431-020-03730-4. Epub 2020 Jul 4.
PubMed 32623628
Study at a glance
From the registry record, last updated by the sponsor on 17 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Delayed Cord Clamping in Preterm Neonates With Placental Insufficiency
- ClinicalTrials.gov ID
- NCT03731546
- Acronym / sponsor ID
- MS/17.04.15
- Keywords
- Delayed cord clamping, Preterm Infant, Placental Insufficiency, Intrauterine growth restriction
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Mansoura University Children HospitalUniversity, hospital or other
- Study start
- 1 Sep 2017 (actual)
- Primary completion
- 1 Mar 2019 (actual)
- Study completion
- 1 Mar 2019 (actual)
- First posted
- 6 Nov 2018 (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 investigate the effect of delayed cord clamping (DCC) on hematopoietic progenitor cells (HPCs), hematological parameters including haemoglobin concentration and hematocrit value in premature infants (34 weeks gestational age or less) with placental insufficiency.We hypothesized that preterm infants with placental insufficiency underwent DDC could have better hematologic parameters and hematopoietic progenitor cells compared to immediate cord clamping.
Detailed description
- A prospective randomized controlled study will be performed on preterm infants 34 weeks gestational age or less with placental insufficiency, and those without placental insufficiency where DCC will be performed in both groups. A third group of preterm with placental insufficiency and immediate cord clamping will be performed as a control.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group A | No intervention | –Placental insufficiency and ICC : Immediate cord clamping after delivery of the fetus in preterm infants with placental insufficiency |
| Group B | Active comparator | Procedure: Delayed cord clampingPlacental insufficiency and DCC: Cord clamping 60 seconds after delivery of fetus in preterm infants with placental insufficiency |
| Group C | Active comparator | Procedure: Delayed cord clampingNormal placenta with DCC:Cord clamping 60 seconds after delivery of fetus in preterm infants without placental insufficiency |
Who may qualify
- Ages
- 0 minutes to 1 minute
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- preterm neonates < 34 weeks gestational age
Key exclusion criteria (1 listed)
- Vaginal bleeding due to placental abruption or tears Multiple pregnancies Suspected major fetal anomalies Suspected chromosomal aberration Maternal drug abuse Hydrops fetalis preterm who needed major resuscitative measures
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 |
|---|---|---|
| Delayed cord clampingCord clamping 60 seconds after delivery of fetus in preterm infants | Procedure or surgery | Group B, Group C |
Primary outcome
Peripheral venous CD34 at admission
Time frame: first 24 hours of infants' life
One milliliter of fetal blood will be taken from peripheral venous blood in the first 30 minutes of life and CD34 will be assessed by flow cytometry.
16 secondary outcomes
Admission hemoglobin
Time frame: first 24 hours of infants' life
Hemoglobin at 2 months
Time frame: 2 months of infants' life
Admission platelets
Time frame: first 24 hours of infants' life
Admission WBCs
Time frame: first 24 hours of infants' life
Phototherapy requirements
Time frame: first 28 days of life
Polycythemia
Time frame: first 28 days of life
Culture proven sepsis
Time frame: first 28 days of life
Necrotizing enterocolitis
Time frame: first 28 days of life
Intraventricular hemorrhage
Time frame: first 28 days of life
Bronchopulmonary dysplasia
Time frame: first 70 days of life
Need for nasal CPAP
Time frame: first 28 days of life
Need for mechanical ventilation
Time frame: first 28 days of life
Duration of oxygen therapy
Time frame: first 28 days of life
Need for inotropes
Time frame: first 28 days of life
Retinopathy of prematurity
Time frame: first 28 days of life
Need for packed RBCs transfusion
Time frame: first 28 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 17 May 2022.
- Background: PubMed 21391876Gokmen Z, Ozkiraz S, Tarcan A, Kozanoglu I, Ozcimen EE, Ozbek N. Effects of delayed umbilical cord clamping on peripheral blood hematopoietic stem cells in premature neonates. J Perinat Med. 2011 May;39(3):323-9. doi: 10.1515/jpm.2011.021. Epub 2011 Mar 11.
- Background: PubMed 23168790Committee on Obstetric Practice, American College of Obstetricians and Gynecologists. Committee Opinion No.543: Timing of umbilical cord clamping after birth. Obstet Gynecol. 2012 Dec;120(6):1522-6. doi: 10.1097/01.AOG.0000423817.47165.48.
- Derived from this study: PubMed 32623628Yunis M, Nour I, Gibreel A, Darwish M, Sarhan M, Shouman B, Nasef N. Effect of delayed cord clamping on stem cell transfusion and hematological parameters in preterm infants with placental insufficiency: a pilot randomized trial. Eur J Pediatr. 2021 Jan;180(1):157-166. doi: 10.1007/s00431-020-03730-4. Epub 2020 Jul 4.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Delayed cord clamping in people with Preterm Infant and Placental Insufficiency, run by Mansoura University Children Hospital 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 1 inclusion and 1 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 17 May 2022. 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.
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?
Peripheral venous CD34 at admission (time frame: first 24 hours of infants' life). 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 NCT03731546, which also lists 3 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 17 May 2022.