Preterm InfantsNCT01487187
The Effect of Cord Milking on Hemodynamic Status of Preterm Infants
A study testing Milking the umbilical cord at birth and immediate umbilical cord clamping in people with Preterm Infants, run by Walid El-Naggar at 1 site in Canada.
Trial summary
Very preterm babies frequently develop problems with their blood circulation during the first few days after birth. These circulation problems could affect the oxygen and blood flow to their brain and lead to effects such as bleeding in the head or delayed developmental milestones later in life. Read more about this study
- Who is it for?
- Ages 24 to 31 weeks
- Conditions the study is for
- Preterm Infants
- What is being tested?
- Milking the umbilical cord at birth and immediate umbilical cord clamping
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 73 participants
- Where
- 1 siteCanada
- Study dates
- Nov 2011to Jan 2018
- 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 24 to 31 weeks
- All sexes
- No healthy volunteers
- Child
Who may be able to join
None listed.
Who cannot join
- monochorionic twin or any higher order multiple pregnancy
- major fetal congenital or chromosomal anomalies
- significant placental abruption
- fetal anemia/transfusion
- Rh isoimmunization
- intent to withhold or withdraw treatment of the infant
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Umbilical Cord Milking on Hemodynamic Status of Preterm Infants: a Randomized Controlled Trial
Very preterm babies frequently develop problems with their blood circulation during the first few days after birth. These circulation problems could affect the oxygen and blood flow to their brain and lead to effects such as bleeding in the head or delayed developmental milestones later in life. Currently the care for such problems may include transfusion of intravenous fluids or blood to the baby and/or giving the baby medications that can help circulation.
The current practice at the delivery of these babies is to immediately clamp their umbilical cords after birth. Recent research studies have shown that giving more of the baby's own blood to them at birth by delayed cord clamping (waiting for clamping the cord for about 30-90 seconds) or by milking the cord, may reduce the number of blood transfusions that these babies may need later on. It may also improve their initial blood pressure and reduce the chances of bleeding in their heads.
Read more
More research is needed to prove if either delayed cord clamping or milking the cord at birth will be better in terms of improving these babies' health.
The aim of this study is to find out if adding some blood to these babies' circulation, through milking the cord at birth, could prevent or reduce the possible problems with blood circulation and the reduced blood flow to the brain that some of these babies may have after birth.
The investigators will also investigate if milking the cord at birth could improve their long-term developmental outcome.
Hypothesis: In preterm infants less than 31 weeks' gestation, milking the umbilical cord 3 times prior to clamping, compared to immediate clamping after birth will improve systemic blood flow (as assessed by improving superior vena cava flow measured by heart ultrasound in the first 24 hours after birth)
Read the detailed description
Eligible mothers will be randomized prior to delivery once preterm labour is established (cervical dilatation > 4cm and preterm birth is considered inevitable or delivery is indicated for maternal or fetal indications) to either milking of the umbilical cord of their infants (intervention group) or to clamp the cord as per standard practice (currently it is the immediate cord clamping) after birth (control group). Randomization will be done in variable block sizes and will be concealed by using opaque envelopes prepared ahead of time from a randomization table. Envelopes will be opened before the time of delivery.
- Conditions
- Preterm Infants
- Being tested
- Milking the umbilical cord at birth, immediate umbilical cord clamping
- Keywords
- Cord-milking, hemodynamic, preterm infants
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Milking the umbilical cord at birthProcedure or surgery
Also called Transfusion of blood from umbilical cord to the baby
Infants in the cord-milked group will be placed at or below the level of the placenta, and about 20 cm of the umbilical cord (or the length of cord that is accessible if less than 20 cm) will be vigorously milked towards the umbilicus three times before clamping the cord
immediate umbilical cord clampingProcedure or surgery
Also called standard practice-cord clamping
immediate cord clamping without milking as per standard practice
| Study group | Role | What they receive |
|---|---|---|
| immediate umbilical cord clamping | Active comparator | The control group will receive immediate cord clamping at birth which is the standard of care in our institution Receives: Procedure: immediate umbilical cord clamping |
| Milking the umbilical cord at birth | Experimental | Infants in the cord-milked group will be placed at or below the level of the placenta, and about 20 cm of the umbilical cord (or the length of cord that is accessible if less than 20 cm) will be vigorously milked towards the umbilicus three times before clamping the cord. Receives: Procedure: Milking the umbilical cord at birth |
What is being measured
The primary outcome is the main question the study is designed to answer.
Systemic blood flow as reflected by mean SVC flow measured by echocardiographic study at 4-6 hours after birth.
Measured: at 4-6 hours of age
Secondary outcomes (7)
low SVC flow (< 40 ml/kg/min), as assessed by echocardiography
Measured: at 4-6 and 10-12 hours of age
Hypotension
Hypotension is defiined as mean blood pressure < corresponding gestational age number for > 30 minutes
Measured: during the first 48 hours of life
Hyperbilirubinemia and peak bilirubin level recording
Hyperbilirubinemia requiring phototherapy (as per routine unit practice)
Measured: during first 2 weeks of age
Systemic blood flow as reflected by mean SVC flow measured by echocardiographic study at 10-12 hours after birth.
Measured: at 10-12 hours of age
Number of blood transfusions during hospital stay
Measured: at 40 weeks of corrected gestational age
Intraventricular hemorrhage (IVH)
Intraventricular hemorrhage (IVH) as diagnosed by standard-practice cranial ultrasounds
Measured: during first 2 weeks of life
Neurodevelopmental outcome
Measured: At 36 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 posted7 Dec 2011 (estimated)
- Study startNov 2011
- Primary completionJan 2018 (estimated)
- Study completionJan 2018 (estimated)
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 InfantsStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 73 participants (actual)
Sponsor and investigators
- Lead sponsor
- Walid El-Naggar
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Walid El-Naggar, IWK Health Centre
- Investigators
- Walid I El-Naggar, MD, Principal investigator, IWK Health Centre- Dalhousie University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01487187
- Sponsor's protocol ID
- 1002554
- Status last verified
- Mar 2017
- First submitted
- 22 Nov 2011
- Last updated
- 9 Mar 2017
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Yes
Publications
El-Naggar W, McMillan D, Hussain A, Armson A, Dodds L, Warren A, Whyte R, Vincer M, Simpson CD. Neurodevelopmental outcomes of very preterm infants who received cord milking at birth: a randomized controlled trial. Eur J Pediatr. 2022 Dec;181(12):4215-4220. doi: 10.1007/s00431-022-04638-x. Epub 2022 Oct 4.
PubMed 36194256El-Naggar W, McMillan D, Hussain A, Armson A, Warren A, Whyte R, Simpson D. The effect of umbilical cord milking on cerebral blood flow in very preterm infants: a randomized controlled study. J Perinatol. 2021 Feb;41(2):263-268. doi: 10.1038/s41372-020-00780-2. Epub 2020 Aug 11.
PubMed 32782323El-Naggar W, Simpson D, Hussain A, Armson A, Dodds L, Warren A, Whyte R, McMillan D. Cord milking versus immediate clamping in preterm infants: a randomised controlled trial. Arch Dis Child Fetal Neonatal Ed. 2019 Mar;104(2):F145-F150. doi: 10.1136/archdischild-2018-314757. Epub 2018 Jun 14.
PubMed 29903720
Study at a glance
From the registry record, last updated by the sponsor on 9 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Umbilical Cord Milking on Hemodynamic Status of Preterm Infants: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT01487187
- Acronym / sponsor ID
- 1002554
- Conditions
- Preterm Infants
- Keywords
- Cord-milking, hemodynamic, preterm infants
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 73 participants (actual)
- Lead sponsor
- Walid El-NaggarUniversity, hospital or other
- Study start
- Nov 2011
- Primary completion
- Jan 2018 (estimated)
- Study completion
- Jan 2018 (estimated)
- First posted
- 7 Dec 2011 (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.
Very preterm babies frequently develop problems with their blood circulation during the first few days after birth. These circulation problems could affect the oxygen and blood flow to their brain and lead to effects such as bleeding in the head or delayed developmental milestones later in life. Currently the care for such problems may include transfusion of intravenous fluids or blood to the baby and/or giving the baby medications that can help circulation.
The current practice at the delivery of these babies is to immediately clamp their umbilical cords after birth. Recent research studies have shown that giving more of the baby's own blood to them at birth by delayed cord clamping (waiting for clamping the cord for about 30-90 seconds) or by milking the cord, may reduce the number of blood transfusions that these babies may need later on. It may also improve their initial blood pressure and reduce the chances of bleeding in their heads.
More research is needed to prove if either delayed cord clamping or milking the cord at birth will be better in terms of improving these babies' health.
The aim of this study is to find out if adding some blood to these babies' circulation, through milking the cord at birth, could prevent or reduce the possible problems with blood circulation and the reduced blood flow to the brain that some of these babies may have after birth.
The investigators will also investigate if milking the cord at birth could improve their long-term developmental outcome.
Hypothesis: In preterm infants less than 31 weeks' gestation, milking the umbilical cord 3 times prior to clamping, compared to immediate clamping after birth will improve systemic blood flow (as assessed by improving superior vena cava flow measured by heart ultrasound in the first 24 hours after birth)
Detailed description
Eligible mothers will be randomized prior to delivery once preterm labour is established (cervical dilatation > 4cm and preterm birth is considered inevitable or delivery is indicated for maternal or fetal indications) to either milking of the umbilical cord of their infants (intervention group) or to clamp the cord as per standard practice (currently it is the immediate cord clamping) after birth (control group). Randomization will be done in variable block sizes and will be concealed by using opaque envelopes prepared ahead of time from a randomization table. Envelopes will be opened before the time of delivery.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| immediate umbilical cord clamping | Active comparator | Procedure: immediate umbilical cord clampingThe control group will receive immediate cord clamping at birth which is the standard of care in our institution |
| Milking the umbilical cord at birth | Experimental | Procedure: Milking the umbilical cord at birthInfants in the cord-milked group will be placed at or below the level of the placenta, and about 20 cm of the umbilical cord (or the length of cord that is accessible if less than 20 cm) will be vigorously milked towards the umbilicus three times before clamping the cord. |
Who may qualify
- Ages
- 24 to 31 weeks
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (0 listed)
Key exclusion criteria (6 listed)
- monochorionic twin or any higher order multiple pregnancy
- major fetal congenital or chromosomal anomalies
- significant placental abruption
- fetal anemia/transfusion
- Rh isoimmunization
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 |
|---|---|---|
| Milking the umbilical cord at birthAlso: Transfusion of blood from umbilical cord to the babyInfants in the cord-milked group will be placed at or below the level of the placenta, and about 20 cm of the umbilical cord (or the length of cord that is accessible if less than 20 cm) will be vigorously milked towards the umbilicus three times before clamping the cord | Procedure or surgery | Milking the umbilical cord at birth |
| immediate umbilical cord clampingAlso: standard practice-cord clampingimmediate cord clamping without milking as per standard practice | Procedure or surgery | immediate umbilical cord clamping |
Primary outcome
Systemic blood flow as reflected by mean SVC flow measured by echocardiographic study at 4-6 hours after birth.
Time frame: at 4-6 hours of age
7 secondary outcomes
low SVC flow (< 40 ml/kg/min), as assessed by echocardiography
Time frame: at 4-6 and 10-12 hours of age
Hypotension
Time frame: during the first 48 hours of life
Hyperbilirubinemia and peak bilirubin level recording
Time frame: during first 2 weeks of age
Systemic blood flow as reflected by mean SVC flow measured by echocardiographic study at 10-12 hours after birth.
Time frame: at 10-12 hours of age
Number of blood transfusions during hospital stay
Time frame: at 40 weeks of corrected gestational age
Intraventricular hemorrhage (IVH)
Time frame: during first 2 weeks of life
Neurodevelopmental outcome
Time frame: At 36 months of age
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Mar 2017.
- Derived from this study: PubMed 36194256El-Naggar W, McMillan D, Hussain A, Armson A, Dodds L, Warren A, Whyte R, Vincer M, Simpson CD. Neurodevelopmental outcomes of very preterm infants who received cord milking at birth: a randomized controlled trial. Eur J Pediatr. 2022 Dec;181(12):4215-4220. doi: 10.1007/s00431-022-04638-x. Epub 2022 Oct 4.
- Derived from this study: PubMed 32782323El-Naggar W, McMillan D, Hussain A, Armson A, Warren A, Whyte R, Simpson D. The effect of umbilical cord milking on cerebral blood flow in very preterm infants: a randomized controlled study. J Perinatol. 2021 Feb;41(2):263-268. doi: 10.1038/s41372-020-00780-2. Epub 2020 Aug 11.
- Derived from this study: PubMed 29903720El-Naggar W, Simpson D, Hussain A, Armson A, Dodds L, Warren A, Whyte R, McMillan D. Cord milking versus immediate clamping in preterm infants: a randomised controlled trial. Arch Dis Child Fetal Neonatal Ed. 2019 Mar;104(2):F145-F150. doi: 10.1136/archdischild-2018-314757. Epub 2018 Jun 14.
- Individual participant dataSharing planned: Yes
Related trials for Preterm Infants
Not yet recruiting
nCPAP-NAVA-Backup Versus Standard nCPAP for Severe Apnea in Preterm Infants ≤28 Weeks
Apnea of Prematurity
Recruiting
Study of the Influence of Intraperitoneal Insufflation of CO2 by Laparoscopy on the Short-term Evolution of Premature Infants With Ulcerative Necrotizing Enterocolitis
Preterm Birth, Enterocolitis, Necrotizing
Recruiting
Comparing Surfactant Administration Through Supraglottic Airway and Thin Catheter for Preterm Infants
Surfactant, Respiratory Distress Syndrome (Neonatal)
Recruiting
Optimization of Saturation Targets And Resuscitation Trial (OptiSTART)
Premature Infants, Bronchopulmonary Dysplasia
RecruitingObservational study
Growing Little PEAPODS Study
Premature Birth, Premature Infant
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.
Walid I El-Naggar, MD principal investigator
IWK Health Centre- Dalhousie University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Milking the umbilical cord at birth and immediate umbilical cord clamping in people with Preterm Infants, run by Walid El-Naggar at 1 site in Canada.
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 0 inclusion and 6 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 9 Mar 2017. 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 Canada. 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?
Results are not available in the source record.
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?
Systemic blood flow as reflected by mean SVC flow measured by echocardiographic study at 4-6 hours after birth. (time frame: at 4-6 hours of age). 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 NCT01487187, 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 9 Mar 2017.