Overview

This trial is active, not recruiting.

Condition preterm infants
Treatments milking the umbilical cord at birth, immediate umbilical cord clamping
Phase phase 2/phase 3
Sponsor Walid El-Naggar
Start date November 2011
End date January 2018
Trial size 73 participants
Trial identifier NCT01487187, 1002554

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)

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking single blind (outcomes assessor)
Primary purpose prevention
Arm
(Active Comparator)
The control group will receive immediate cord clamping at birth which is the standard of care in our institution
immediate umbilical cord clamping standard practice-cord clamping
immediate cord clamping without milking as per standard practice
(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.
milking the umbilical cord at birth 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

Primary Outcomes

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

Secondary Outcomes

Measure
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

Eligibility Criteria

Male or female participants from 24 weeks up to 31 weeks old.

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

Additional Information

Official title The Effect of Umbilical Cord Milking on Hemodynamic Status of Preterm Infants: a Randomized Controlled Trial
Principal investigator Walid I El-Naggar, MD
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.
Trial information was received from ClinicalTrials.gov and was last updated in August 2015.
Information provided to ClinicalTrials.gov by IWK Health Centre.