Placental InsufficiencyNCT03731611
Impact of Umbilical Cord Milking in Preterm Neonates With Placental Insufficiency
A study testing Umbilical Cord Milking in people with Placental Insufficiency and Preterm Infant, run by Mansoura University Children Hospital at 2 sites in Egypt.
Trial summary
To investigate the effect of umbilical cord milking (UCM) on peripheral hematologic parameters including hematopoietic progenitor cells in premature infants ≤ 34 weeks gestational age with placental insufficiency. Read more about this study
- Who is it for?
- Ages 0 minutes and older
- Conditions the study is for
- Placental Insufficiency, Preterm Infant
- What is being tested?
- Umbilical Cord Milking
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 2 sitesEgypt
- Study dates
- 1 Apr 2019to 30 Mar 2020
- 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 and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
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
2 sites in 1 country.
Egypt2 sites
Mansoura University Children Hospital
Al Mansurah, El Dakahlya, 35111
Mansoura University Children's Hospital
Al Mansurah
About this study
To investigate the effect of umbilical cord milking (UCM) on peripheral hematologic parameters including hematopoietic progenitor cells in premature infants ≤ 34 weeks gestational age with placental insufficiency. We hypothesize that UCM would enhance peripheral CD34 concentration, hemoglobin and reduce prematurity complications like NEC and IVH in preterm infant ≤ 34 week gestational age with placental insufficiency.
Read the detailed description
A pilot prospective randomized controlled study will be conducted among 3 groups, all of them are preterm less than 34 weeks gestational age, in the first group umbilical cord milking will be done for preterm infant with placental insufficiency. Two control groups are present, in the first one umbilical cord milking will be done for preterm infants without placental insufficiency (Insufficiency vs. no insufficiency), another group of immediate cord clamping for preterm infants with placental insufficiency will be added (milking vs. no milking), 30 cases will be recruited in each group.
Umbilical cord milking (UCM) is typically performed by placing the infant below the level of the placenta. The cord is held at 20-25 cm distance from the baby and milked vigorously towards the umbilicus for 3 times at a speed of 10 cm/sec. After completion, the cord is clamped, and the neonate is handed to the resuscitation team.
One milliliter of fetal blood will be taken from peripheral venous blood in the first 30 min of life and CD34 will be assessed by flow cytometry. Secondary outcomes will be documented during NICU stay that include admission CBC, peak bilirubin concentrations, CBC after 2 months, neonatal morbidity such as sepsis, bronchopulmonary dysplasia, necrotizing enterocolitis, retinopathy of prematurity and polycythemia, therapeutic interventions such as need for inotropes, nasal CPAP, mechanical ventilation and phototherapy.
- Conditions
- Placental Insufficiency, Preterm Infant
- Being tested
- Umbilical Cord Milking
- Keywords
- Umbilical cord milking
- Medical subject headings
- Placental Insufficiency, Premature Birth
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Umbilical Cord MilkingProcedure or surgery
Umbilical cord milking (UCM) is typically performed by placing the infant below the level of the placenta. The cord is held at 20-25 cm distance from the baby and milked vigorously towards the umbilicus for 3 times at a speed of 10 cm/sec. After completion, the cord is clamped, and the neonate is handed to the resuscitation team.
| Study group | Role | What they receive |
|---|---|---|
| Group A | Active comparator | umbilical cord milking will be done for preterm infants <34 gestational age without placental insufficiency Receives: Procedure: Umbilical Cord Milking |
| Group B | Active comparator | umbilical cord milking will be done for preterm infant <34 gestational age with placental insufficiency Receives: Procedure: Umbilical Cord Milking |
| Group C | No intervention | Immediate cord clamping for preterm infants <34 gestational age with placental insufficiency |
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 min 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 after umbilical cord milking
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 hours of life.
Measured: first 24 hours of infants' life
Phototherapy requirements
Need to start phototherapy for hyperbilirubinemia
Measured: first 28 days of life
Polycythemia
arterial Hematocrit value more than 70%
Measured: first 28 days of life
Culture proven sepsis
Sepsis confirmed by positive blood culture
Measured: first 28 days of life
Necrotizing enterocolitis
Necrotizing enterocolitis (Any Bell's stage)
Measured: first 28 days of life
Intraventricular hemorrhage
Intraventricular hemorrhage of all grades
Measured: first 28 days of life
Bronchopulmonary dysplasia
Oxygen requirement at 36 weeks corrected gestational age
Measured: first 70 days of life
Need for packed RBCs transfusion
number of packed RBCs transfusion
Measured: first 28 days of life
Retinopathy of prematurity
Prethreshold and threshold diseases Retinopathy of prematurity
Measured: first 28 days of life
Need for inotropes
Hypotension requiring inotropic support
Measured: first 28 days of life
Need for nasal CPAP
respiratory distress requiring CPAP support
Measured: first 28 days of life
Need for mechanical ventilation
respiratory distress requiring mechanical ventilation support
Measured: first 28 days of life
Duration of oxygen therapy
Duration of oxygen therapy
Measured: first 70 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 Apr 2019
- Primary completion1 Mar 2020
- Study completion30 Mar 2020
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 Placental InsufficiencyStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- 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
- NCT03731611
- Sponsor's protocol ID
- MS/17.07.44
- Status last verified
- May 2022
- First submitted
- 3 Nov 2018
- Last updated
- 3 May 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Li J, Yu B, Wang W, Luo D, Dai QL, Gan XQ. Does intact umbilical cord milking increase infection rates in preterm infants with premature prolonged rupture of membranes? J Matern Fetal Neonatal Med. 2020 Jan;33(2):184-190. doi: 10.1080/14767058.2018.1487947. Epub 2018 Sep 6.
PubMed 29886779Kumar B, Upadhyay A, Gothwal S, Jaiswal V, Joshi P, Dubey K. Umbilical Cord Milking and Hematological Parameters in Moderate to Late Preterm Neonates: A Randomized Controlled Trial. Indian Pediatr. 2015 Sep;52(9):753-7. doi: 10.1007/s13312-015-0711-1.
PubMed 26519708
Study at a glance
From the registry record, last updated by the sponsor on 3 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Umbilical Cord Milking in Preterm Neonates With Placental Insufficiency
- ClinicalTrials.gov ID
- NCT03731611
- Acronym / sponsor ID
- MS/17.07.44
- Conditions
- Placental Insufficiency, Preterm Infant
- Keywords
- Umbilical cord milking
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Mansoura University Children HospitalUniversity, hospital or other
- Study start
- 1 Apr 2019 (actual)
- Primary completion
- 1 Mar 2020 (actual)
- Study completion
- 30 Mar 2020 (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 umbilical cord milking (UCM) on peripheral hematologic parameters including hematopoietic progenitor cells in premature infants ≤ 34 weeks gestational age with placental insufficiency. We hypothesize that UCM would enhance peripheral CD34 concentration, hemoglobin and reduce prematurity complications like NEC and IVH in preterm infant ≤ 34 week gestational age with placental insufficiency.
Detailed description
A pilot prospective randomized controlled study will be conducted among 3 groups, all of them are preterm less than 34 weeks gestational age, in the first group umbilical cord milking will be done for preterm infant with placental insufficiency. Two control groups are present, in the first one umbilical cord milking will be done for preterm infants without placental insufficiency (Insufficiency vs. no insufficiency), another group of immediate cord clamping for preterm infants with placental insufficiency will be added (milking vs. no milking), 30 cases will be recruited in each group.
Umbilical cord milking (UCM) is typically performed by placing the infant below the level of the placenta. The cord is held at 20-25 cm distance from the baby and milked vigorously towards the umbilicus for 3 times at a speed of 10 cm/sec. After completion, the cord is clamped, and the neonate is handed to the resuscitation team.
One milliliter of fetal blood will be taken from peripheral venous blood in the first 30 min of life and CD34 will be assessed by flow cytometry. Secondary outcomes will be documented during NICU stay that include admission CBC, peak bilirubin concentrations, CBC after 2 months, neonatal morbidity such as sepsis, bronchopulmonary dysplasia, necrotizing enterocolitis, retinopathy of prematurity and polycythemia, therapeutic interventions such as need for inotropes, nasal CPAP, mechanical ventilation and phototherapy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group A | Active comparator | Procedure: Umbilical Cord Milkingumbilical cord milking will be done for preterm infants <34 gestational age without placental insufficiency |
| Group B | Active comparator | Procedure: Umbilical Cord Milkingumbilical cord milking will be done for preterm infant <34 gestational age with placental insufficiency |
| Group C | No intervention | –Immediate cord clamping for preterm infants <34 gestational age with placental insufficiency |
Who may qualify
- Ages
- 0 minutes and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- preterm neonates < 34 weeks gestational age
Key exclusion criteria (7 listed)
- Vaginal bleeding due to placental abruption or tears
- Multiple pregnancies
- Suspected major fetal anomalies
- Suspected chromosomal aberration
- Maternal drug abuse
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 |
|---|---|---|
| Umbilical Cord MilkingUmbilical cord milking (UCM) is typically performed by placing the infant below the level of the placenta. The cord is held at 20-25 cm distance from the baby and milked vigorously towards the umbilicus for 3 times at a speed of 10 cm/sec. After completion, the cord is clamped, and the neonate is handed to the resuscitation team. | Procedure or surgery | Group A, Group B |
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 min 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 after umbilical cord milking
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 packed RBCs transfusion
Time frame: first 28 days of life
Retinopathy of prematurity
Time frame: first 28 days of life
Need for inotropes
Time frame: first 28 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 70 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 3 May 2022.
- Results publication: PubMed 29886779Li J, Yu B, Wang W, Luo D, Dai QL, Gan XQ. Does intact umbilical cord milking increase infection rates in preterm infants with premature prolonged rupture of membranes? J Matern Fetal Neonatal Med. 2020 Jan;33(2):184-190. doi: 10.1080/14767058.2018.1487947. Epub 2018 Sep 6.
- Results publication: PubMed 26519708Kumar B, Upadhyay A, Gothwal S, Jaiswal V, Joshi P, Dubey K. Umbilical Cord Milking and Hematological Parameters in Moderate to Late Preterm Neonates: A Randomized Controlled Trial. Indian Pediatr. 2015 Sep;52(9):753-7. doi: 10.1007/s13312-015-0711-1.
- 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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Umbilical Cord Milking in people with Placental Insufficiency and Preterm Infant, run by Mansoura University Children Hospital at 2 sites 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 7 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 3 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 2 sites 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 NCT03731611, 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 3 May 2022.