Clinical trial NCT01487187: The Effect of Cord Milking on Hemodynamic Status of Preterm Infants
Official title: The Effect of Umbilical Cord Milking on Hemodynamic Status of Preterm Infants: a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Preterm Infants
Keywords: Cord-milking
hemodynamic
preterm infants
Lead sponsor: IWK Health Centre
Sponsor class: OTHER
First posted: 2011-12-07
Enrollment: 73
Sex: ALL
Minimum age (years): 24
Maximum age (years): 31
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief 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. 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.

Eligibility criteria: Inclusion Criteria:Preterm infants \< 31 weeks' gestation if their mothers fulfill the following inclusion criteria:

1. 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).
2. at 24+0 weeks - 30+6/7 weeks gestation (by best estimate based on date of last menstrual period or early ultrasound)

Exclusion Criteria:

1. monochorionic twin or any higher order multiple pregnancy
2. major fetal congenital or chromosomal anomalies
3. significant placental abruption
4. fetal anemia/transfusion
5. Rh isoimmunization
6. intent to withhold or withdraw treatment of the infant

Primary outcomes:
measure: Systemic blood flow as reflected by mean SVC flow measured by echocardiographic study at 4-6 hours after birth.
timeFrame: at 4-6 hours of age
Secondary outcomes:
measure: low SVC flow (< 40 ml/kg/min), as assessed by echocardiography
timeFrame: at 4-6 and 10-12 hours of age
measure: Hypotension
timeFrame: during the first 48 hours of life
measure: Hyperbilirubinemia and peak bilirubin level recording
timeFrame: during first 2 weeks of age
measure: Systemic blood flow as reflected by mean SVC flow measured by echocardiographic study at 10-12 hours after birth.
timeFrame: at 10-12 hours of age
measure: Number of blood transfusions during hospital stay
timeFrame: at 40 weeks of corrected gestational age
measure: Intraventricular hemorrhage (IVH)
timeFrame: during first 2 weeks of life
measure: Neurodevelopmental outcome
timeFrame: At 36 months of age
Other outcomes:
Locations:
city: Halifax
country: Canada
facility: IWK Health Centre
state: Nova Scotia
Study officials:
affiliation: IWK Health Centre- Dalhousie University
name: Walid I El-Naggar, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.