- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01487187
The Effect of Cord Milking on Hemodynamic Status of Preterm Infants
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.
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)
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Nova Scotia
-
Halifax, Nova Scotia, Canada
- IWK Health Centre
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:Preterm infants < 31 weeks' gestation if their mothers fulfill the following inclusion criteria:
- admitted to the hospital for at least 2 hours before delivery in preterm labor (cervical dilatation >2 cm or having premature rupture of membranes) or if a decision to induce labour has been made by treating physician for a maternal or fetal indications).
- at 24+0 weeks - 30+6/7 weeks gestation (by best estimate based on date of last menstrual period or early ultrasound)
Exclusion Criteria:
- 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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: immediate umbilical cord clamping
The control group will receive immediate cord clamping at birth which is the standard of care in our institution
|
immediate cord clamping without milking as per standard practice
Other Names:
|
Experimental: Milking the umbilical cord at birth
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.
|
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
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
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
|
at 4-6 hours of age
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
low SVC flow (< 40 ml/kg/min), as assessed by echocardiography
Time Frame: at 4-6 and 10-12 hours of age
|
at 4-6 and 10-12 hours of age
|
|
Hypotension
Time Frame: during the first 48 hours of life
|
Hypotension is defiined as mean blood pressure < corresponding gestational age number for > 30 minutes
|
during the first 48 hours of life
|
Hyperbilirubinemia and peak bilirubin level recording
Time Frame: during first 2 weeks of age
|
Hyperbilirubinemia requiring phototherapy (as per routine unit practice)
|
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
|
at 10-12 hours of age
|
|
Number of blood transfusions during hospital stay
Time Frame: at 40 weeks of corrected gestational age
|
at 40 weeks of corrected gestational age
|
|
Intraventricular hemorrhage (IVH)
Time Frame: during first 2 weeks of life
|
Intraventricular hemorrhage (IVH) as diagnosed by standard-practice cranial ultrasounds
|
during first 2 weeks of life
|
Neurodevelopmental outcome
Time Frame: At 36 months of age
|
At 36 months of age
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Walid I El-Naggar, MD, IWK Health Centre- Dalhousie University
Publications and helpful links
General 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.
- El-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.
- El-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.
Study record dates
Study Major Dates
Study Start
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 1002554
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Preterm Infants
-
Hadassah Medical OrganizationWithdrawnPreterm Infants With White Matter Damage | Preterm Infants Developing Normally
-
Children's Hospital of Fudan UniversityCompleted
-
Abbott NutritionCompleted
-
Mansoura UniversityCompletedPreterm Infants
-
Seoul National University HospitalRecruitingPreterm InfantsKorea, Republic of
-
Baskent UniversityUnknownPreterm InfantsTurkey
-
Nantes University HospitalTerminated
-
Shanghai Jiao Tong University School of MedicineUnknownPreterm InfantsChina
Clinical Trials on immediate umbilical cord clamping
-
Fondazione Poliambulanza Istituto OspedalieroCompleted
-
University of Rhode IslandNational Institute of Nursing Research (NINR); Brown University; Women and Infants...CompletedSepsis | Intraventricular HemorrhageUnited States
-
Ankara UniversityUnknownPlacental Transfusion | Stem Cells
-
Lady Hardinge Medical CollegeRecruitingPerinatal Asphyxia | Hypoxic-Ischemic EncephalopathyIndia
-
Policlinico Abano TermeUnknown
-
Sharp HealthCareCompleted
-
Uppsala UniversityUmeå University; Halmstad County Hospital; County Council of Halland, SwedenCompletedIron Deficiency | Developmental DelaySweden
-
Acibadem UniversityCompletedCesarean Delivery | Delayed Separation of Umbilical CordTurkey
-
University Hospital, LilleMinistry of Health, FranceRecruiting
-
University of OklahomaCompletedPreTerm Birth | PreTerm NeonateUnited States