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The Risk of Hyperbilirubinemia in Term Newborns After Placental Transfusion

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ClinicalTrials.gov Identifier: NCT02625688
Recruitment Status : Completed
First Posted : December 9, 2015
Last Update Posted : March 28, 2017
Sponsor:
Collaborator:
Medical University of Warsaw
Information provided by (Responsible Party):
Joanna Seliga-Siwecka, Princess Anna Mazowiecka Hospital, Warsaw, Poland

Brief Summary:

Delayed cord clamping (DCC) has been a subject of extensive research for the last couple of years. Based on published data, numerous neonatal benefits have been suggested such as increased hemoglobin and ferritin levels both at birth and longer term. Available systematic reviews of DCC versus early cord clamping (ECC) reveal that it may also contribute to other neonatal outcomes including polycythemia and hyperbilirubinemia.

A review published nearly 10 years ago regarding late umbilical cord clamping revealed only 4 studies which as a second objective assessed whether the time of cord clamping was associated with an increased risk of polycythemia and hyperbilirubinemia during the first week of life. Two studies reported that neonates with DCC had bilirubin levels >15 mg/dl. No information is provided on what hour of life the bilirubin levels were measured exactly.

In this randomized control study the investigators would like to determine if delayed cord clamping or cord milking during labor increases the risk of hyperbilirubinaemia (requiring phototherapy) in term infants.


Condition or disease Intervention/treatment Phase
Jaundice Neonatal Other: Delayed cord clamping Other: Cord milking Other: Early cord clamping Not Applicable

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 400 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: The Risk of Hyperbilirubinemia in Term Newborns After Placental Transfusion: A Randomized-blinded Controlled Trial
Study Start Date : August 2013
Actual Primary Completion Date : June 2016
Actual Study Completion Date : December 2016

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Placebo Comparator: Early cord clamping
Cord clamping will be applied after 30 seconds post delivery.
Other: Early cord clamping
We have decided to clamp the cord in the early intervention group at 30 seconds and place the baby 10 cm above the placental, as it seems most efficient based on the available literature. At all births (spontaneous vaginal deliveries and caesarian sections) a member of the recruitment team will be present. He will inform the midwife or obstetrician about the allocated intervention and measure the time from the delivery of the shoulders to the cord clamping.

Active Comparator: Delayed cord clamping
Cord clamping will be applied after 3 minutes post delivery.
Other: Delayed cord clamping
We have decided to delay cord clamping in the intervention group to 3 minutes and place the baby 10 cm above the placental, as it seems most efficient based on the available literature. At all births (spontaneous vaginal deliveries and caesarian sections) a member of the recruitment team will be present. He will inform the midwife or obstetrician about the allocated intervention and measure the time from the delivery of the shoulders to the cord clamping.

Active Comparator: Cord milking
The baby will be placed below the level of the placenta, between the mother's thighs (during a vaginal delivery) or at the side of the mother swaddled in sterile towels (during a caesarian delivery).
Other: Cord milking
If cord milking will be the allocated intervention, the recruiter will supervise the midwife, or obstetrician preforming the procedure, and count out loud the number of times the cord has been milked. During vaginal deliveries midwifes will be asked to maintain the infant at least 10 cm above the uterus until the cord is clamped. In case of caesarian sections the baby will be placed on the mother's laps and swaddled in sterile towels to prevent heat loss.




Primary Outcome Measures :
  1. The number of patients with hyperbilirubinemia requiring phototherapy or exchange transfusion. [ Time Frame: 14 days of life ]
    Infants requiring phototherapy or exchange transfusion will be evaluated according to the AAP guidelines. The above evidence based guidelines describe the management of neonatal hyperbilirubinaemia in newborns above 35 weeks of gestation. Serum bilirubin levels will be interpreted according to the baby's age in hours. Physicians assessing the infant and prescribing phototherapy will be blinded to treatment.


Secondary Outcome Measures :
  1. The number of patients with polycythemia defined as a hematocrit > 65%. [ Time Frame: 48-72 hours of life. ]
    Hematocrit levels peak at about 2 hours of age, and gradually stabilize during the following 12-24 hours. To avoid bias and minimalize the amount of needle pricks we have chosen to combine serum bilirubin and hematological measurements to the minimal amount of samples .

  2. The number of patients with symptomatic polycythemia (hematocrit > 75%), and non - symptomatic polycythemia (hematocrit >80%). [ Time Frame: 48-72 hours of life ]
    Symptomatic polycythemia (hematocrit > 75%), non - symptomatic polycythemia (hematocrit >80%) requiring exchange transfusion during the 48-72 hours of life

  3. The number of patients with symptomatic polycythemia defined as lethargy, plethora, jitteriness, tachycardia, tachypnea [ Time Frame: 48-72 hours of life ]
  4. The number of patients with congenital anemia [ Time Frame: at birth ]
    cord Hb <12.5 g/dL



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Ages Eligible for Study:   37 Weeks to 42 Weeks   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria

All maternal-fetal dyads must comply with all of the following at randomization:

  • Term delivery between 37 -42 weeks of gestation (estimated by ultrasound).
  • Signed parental consent.
  • Singleton delivery.
  • Nonsmoking mothers.
  • Mothers willing to return for follow up visits.
  • Declaration of breastfeeding for at least six months.

Exclusion Criteria The following maternal - fetal dyads will be excluded

  1. Preterm delivery < 37 weeks of gestation (estimated by ultrasound).
  2. Isoimmune hemolytic disease.
  3. Sepsis.
  4. Maternal Gilbert syndrome.
  5. Birth asphyxia.
  6. Serious maternal hemorrhage during delivery.
  7. Major congenital abnormalities.
  8. Need for early cord clamping (tight nuchal cord, need for resuscitation).
  9. Participation in another trial.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02625688


Locations
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Poland
Department of Neonatology and Neonatal Intensive Care Warsaw Medical University
Warsaw, Poland, 00-315
Sponsors and Collaborators
Princess Anna Mazowiecka Hospital, Warsaw, Poland
Medical University of Warsaw
Investigators
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Principal Investigator: Joanna Seliga-Siwecka, MD Phd Medical University of Warsaw

Publications:
Ceriani, R.J., Ferreira C. P. , M. A., Effect of Timing of Cord Clamping on Postnatal Hematocrit Values and Clinical Outcome in Term Infants. A Randomized, Controlled Trial. Pediatr Res, 2005. 57(6): p. 922-922.
Bhutani, V.K., Screening for severe neonatal hyperbilirubinemia. Pediatric Health, 2009. 3(4): p. 369-379.

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Responsible Party: Joanna Seliga-Siwecka, Assistant, Princess Anna Mazowiecka Hospital, Warsaw, Poland
ClinicalTrials.gov Identifier: NCT02625688     History of Changes
Other Study ID Numbers: 1/2013
First Posted: December 9, 2015    Key Record Dates
Last Update Posted: March 28, 2017
Last Verified: March 2017
Additional relevant MeSH terms:
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Jaundice
Hyperbilirubinemia
Pathologic Processes
Skin Manifestations
Signs and Symptoms