Clinical Trial: The Risk of Hyperbilirubinemia in Term Newborns After Placental Transfusion

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: The Risk of Hyperbilirubinemia in Term Newborns After Placental Transfusion: A Randomized-blinded Controlled Trial

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.


Detailed Summary:

The investigators feel that published results regarding 'jaundice" and "jaundice needing phototherapy' (associated with DCC) may be misleading.

First, no information is offered about how "clinical jaundice "was assessed on examination. The absence of jaundice is not an indication of the absence of hyperbilirubinemia. Estimation of the degree of hyperbilirubinemia based solely on clinical examination can lead to errors. The absence or the severity of jaundice is not predictive of subsequent severe hyperbilirubinemia. A recent study revealed that the nurses' predischarge assessment of jaundice extent was only moderately correlated with bilirubin concentration and was similar in black and nonblack infants.

A review published nearly 10 years ago regarding late umbilical cord clamping revealed only 4 studies which as a secondary objective which 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.

Secondly, guidelines to treat jaundice have changed over time and none of the studies mention what threshold was used for administering phototherapy. No information is given if, staff responsible for phototherapy administration was blinded to the type of cord clamping intervention. Potential confounders such as isoimmune hemolytic disease, symptoms of sepsis (significant lethargy, temperature instability), asphyxia, G6PD, acidosis, albumin <3 g/L were not included in the analysis. Also another important factor such feeding policy at the time of bilirubin measurement wasn't mentioned in neither of the
Sponsor: Princess Anna Mazowiecka Hospital, Warsaw, Poland

Current Primary Outcome: 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.


Original Primary Outcome: Same as current

Current Secondary Outcome:

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


Original Secondary Outcome: Same as current

Information By: Princess Anna Mazowiecka Hospital, Warsaw, Poland

Dates:
Date Received: November 26, 2015
Date Started: August 2013
Date Completion:
Last Updated: March 27, 2017
Last Verified: March 2017