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. 2019 Sep 17;2019(9):CD003248. doi: 10.1002/14651858.CD003248.pub4

Backes 2016.

Methods Randomised controlled trial
Participants Inclusion criteria
  • Pregnant women 22.5 to 27.6 weeks' gestation.

  • Singleton pregnancies

  • N = 40 babies include


Exclusion criteria
  • Women whose pregnancies were complicated by placental abruption, placental previa, multiple gestations, chromosomal abnormalities (including trisomy 21), known major congenital malformations, attending obstetrician refusal to participate or intent to withhold care.

Interventions Intervention: DCC
  • Cord clamping at 30‐45 secs

  • The obstetrician clamped the umbilical cord 30 to 45 secs following delivery of the infant.

  • During the delay, the infant was held in a sterile towel approximately 10 to 15 inches below the mother’s introitus at vaginal delivery or below the level of the incision at CS.

  • A member of the research team notified the delivering physician regarding time elapsed in 5‐sec intervals.

  • Following clamping of the umbilical cord, the infant was handed to the neonatology team for routine infant care

  • N = 18 babies


Comparator: ECC
  • Clamping at less than 10 secs

  • The obstetrician clamped the umbilical cord immediately following delivery of the infant.

  • N = 22 babies


Additional information
  • Gestational subgroup: < 32‐34 weeks' gestation

  • Resuscitation with cord intact: not available

  • Access to NICU: yes

  • Length of delay: 30‐45 secs

  • Baby placed: low

  • Uterotonic: no information

  • UCM: n/a


Comparison 1
DCC with neonatal resuscitation after cord clamping vs ECC (subgroup by gestation)
Subgroup 1: < 32‐34 weeks' gestation
Comparison 2
DCC with neonatal resuscitation after cord clamping vs ECC (subgroup by type of intervention)
Subgroup 2: DCC at < 1 min with baby low (+ gravity)
Outcomes Circulating progenitor cell types in postnatal days 1‐30; IVH grades 3 and 4; Infant mortality; infant Hct.
Notes Setting: nationwide Children's Hospital, Ohio State University Wexner Medical Center, Ohio, USA
Dates: August 2009 to December 2013
Declaration of interest: quote:"The authors declare no conflict of interest.".
Trial funding source: quote:“The present work is supported in part by a grant from the American Heart Association (# 10CRP3730033, CHB) and by internal funding provided by Nationwide Children’s Hospital Research Institute.”.
Further information
  • Huang 2016 reports no difference in Baileys at 6‐9 months nor at 12‐18 months.

  • In entering data, we have re‐included, in deaths and in the denominators, the 3 babies who died on delivery suite, 1 in DCC and 2 in ICC, so the denominators are 18 and 22 babies.

  • We have written to Professor Backes regarding clarification on the data on surfactant for severe RDS and we are awaiting a reply.

Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk Quote:"A random number system was generated by a statistician not involved in the study."
Allocation concealment (selection bias) Low risk Quote:“Laminated cards for randomization were maintained in sealed, opaque envelopes. Study personnel provided contact information to labor and delivery staff to notify them of potential study participants or the impending delivery of previously enrolled subjects. When called for a subject’s impending delivery, the team member opened the next randomization card..."
Blinding of participants and personnel (performance bias) 
 All outcomes High risk Cannnot blind clinicians to intervention, and no information as to whether women knew or not.
Blinding of outcome assessment (detection bias) 
 All outcomes Low risk Quote:“None of the study members present at the time of randomization or aware
of group assignment participated in the daily clinical care of study patients.”
Incomplete outcome data (attrition bias) 
 All outcomes Low risk 40 infants enrolled and no losses, although authors did exclude babies who died on delivery suite from their denominator data but we will include these babies in our denominator data as normal.
Selective reporting (reporting bias) Unclear risk We did not assess the trial protocol.
Other bias Low risk Baseline characteristics similar (gestational age; gender; small for gestational age; birthweight. No infants assigned to DCC received ECC to expedite resuscitation. No other biases apparent.