The Risk of Hyperbilirubinemia in Term Newborns After Placental Transfusion

NCT02625688 | Completed

• 1 other identifier: 1/2013
• Study Type: interventional
• Target: 400
• Locations: 1 country
• Sites: 1

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.

Conditions

Jaundice Neonatal

Outcome Measures

Primary Outcomes (1)

• The number of patients with hyperbilirubinemia requiring phototherapy or exchange transfusion.

  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.

  14 days of life

Secondary Outcomes (4)

• The number of patients with polycythemia defined as a hematocrit > 65%.

  48-72 hours of life.

• The number of patients with symptomatic polycythemia (hematocrit > 75%), and non - symptomatic polycythemia (hematocrit >80%).

  48-72 hours of life

• The number of patients with symptomatic polycythemia defined as lethargy, plethora, jitteriness, tachycardia, tachypnea

  48-72 hours of life

• The number of patients with congenital anemia

  at birth

Study Arms (3)

Early cord clamping

PLACEBO COMPARATOR

Cord clamping will be applied after 30 seconds post delivery.

Other: Early cord clamping

Delayed cord clamping

ACTIVE COMPARATOR

Cord clamping will be applied after 3 minutes post delivery.

Other: Delayed cord clamping

Cord milking

ACTIVE COMPARATOR

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

Interventions

Delayed cord clamping OTHER

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.

Delayed cord clamping

Cord milking OTHER

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.

Cord milking

Early cord clamping OTHER

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.

Early cord clamping

Eligibility Criteria

• Age: 37 Weeks - 42 Weeks
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• Preterm delivery \< 37 weeks of gestation (estimated by ultrasound).
• Isoimmune hemolytic disease.
• Sepsis.
• Maternal Gilbert syndrome.
• Birth asphyxia.
• Serious maternal hemorrhage during delivery.
• Major congenital abnormalities.
• Need for early cord clamping (tight nuchal cord, need for resuscitation).
• Participation in another trial.

Sponsors & Collaborators

• Princess Anna Mazowiecka Hospital, Warsaw, Poland: lead
• Medical University of Warsaw: collaborator

Study Sites (1)

Department of Neonatology and Neonatal Intensive Care Warsaw Medical University

Warsaw, 00-315, Poland

Location

Related Publications (8)

• Bhutani VK, Gourley GR, Adler S, Kreamer B, Dalin C, Johnson LH. Noninvasive measurement of total serum bilirubin in a multiracial predischarge newborn population to assess the risk of severe hyperbilirubinemia. Pediatrics. 2000 Aug;106(2):E17. doi: 10.1542/peds.106.2.e17.

  PMID: 10920173 BACKGROUND

• Rubaltelli FF, Gourley GR, Loskamp N, Modi N, Roth-Kleiner M, Sender A, Vert P. Transcutaneous bilirubin measurement: a multicenter evaluation of a new device. Pediatrics. 2001 Jun;107(6):1264-71. doi: 10.1542/peds.107.6.1264.

  PMID: 11389241 BACKGROUND

• Bhutani VK, Johnson L, Sivieri EM. Predictive ability of a predischarge hour-specific serum bilirubin for subsequent significant hyperbilirubinemia in healthy term and near-term newborns. Pediatrics. 1999 Jan;103(1):6-14. doi: 10.1542/peds.103.1.6.

  PMID: 9917432 BACKGROUND

• Keren R, Tremont K, Luan X, Cnaan A. Visual assessment of jaundice in term and late preterm infants. Arch Dis Child Fetal Neonatal Ed. 2009 Sep;94(5):F317-22. doi: 10.1136/adc.2008.150714. Epub 2009 Mar 22.

  PMID: 19307221 BACKGROUND

• McDonald SJ, Middleton P. Effect of timing of umbilical cord clamping of term infants on maternal and neonatal outcomes. Cochrane Database Syst Rev. 2008 Apr 16;(2):CD004074. doi: 10.1002/14651858.CD004074.pub2.

  PMID: 18425897 BACKGROUND

• Gupta R, Ramji S. Effect of delayed cord clamping on iron stores in infants born to anemic mothers: a randomized controlled trial. Indian Pediatr. 2002 Feb;39(2):130-5.

  PMID: 11867842 BACKGROUND

• 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.

  BACKGROUND

• Bhutani, V.K., Screening for severe neonatal hyperbilirubinemia. Pediatric Health, 2009. 3(4): p. 369-379.

  BACKGROUND

MeSH Terms

Conditions

Jaundice, Neonatal

Interventions

Umbilical Cord Clamping

Condition Hierarchy (Ancestors)

Hyperbilirubinemia, Neonatal; Infant, Newborn, Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Hyperbilirubinemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Delivery, Obstetric; Obstetric Surgical Procedures; Surgical Procedures, Operative

Study Officials

• Joanna Seliga-Siwecka, MD Phd

  Medical University of Warsaw

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant

Study Record Dates

• First Submitted: November 26, 2015
• First Posted: December 9, 2015
• Study Start: August 1, 2013
• Primary Completion: June 1, 2016
• Study Completion: December 1, 2016
• Last Updated: March 28, 2017

Record last verified: 2017-03

Locations

PL (1)