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

Hosono 2015.

Methods Randomised controlled trial ‐ multicentre (14 centres)
Participants Inclusion criteria
  • Preterm neonates 24 to 276 weeks' gestation

  • No information as to whether dichorionic twins were included or not

  • N = 203 babies were randomised in 14 centres. Data available on 154 infants. No information about losses after randomisation (= 24%)


Exclusion criteria
  • Major anomalies diagnosed in utero; IUGR (less than 3 SD); monochorionic twins; super twins

Interventions Intervention: UCM
  • Cord clamped at 30 cm from infant.

  • Baby placed on radiant warmer

  • Cord milked just once

  • N = 102 babies but only 77 analysed. 62 analysed at follow‐up


Comparator: ECC
  • Cord clamped within 30 secs

  • N = 101 babies but only 77 analysed. 63 analysed at follow‐up


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

  • Resuscitation with cord intact: not available

  • Access to NICU: yes

  • Length of delay: n/a

  • Baby placed: no information so assume level with uterus and placenta

  • Uterotonic: no information

  • UCM: cord cut before milking


Comparison 7
UCM vs ECC (subgroup by gestation)
Subgroup 1: < 32‐34 weeks' gestation
Comparison 8
UCM vs ECC (subgroup by type of intervention)
Subgroup 2: cord cut before UCM
Outcomes Primary
  • Death; probability of not needing transfusion; amount of blood transfused in first 4 weeks


Secondary
  • Mortality; major complications (IVH; chronic lung disease; PVL; RoP; intestinal perforation); serious adverse event; Hb within 24 hrs; stabilisation of BP and use of volume expander and/or inotrope; polycythaemia; hyperbilirubinaemia; developmental disorder at 18 months and 3 years (neurodevelopmental delay; CP; epilepsy; visual impairment; hearing loss).

Notes Setting: Japan in 14 centres
Dates: January 2008 to December 2013
Declaration of interest: not reported.
Trial funding source: The Ministry of Health, Labour and Welfare
Further information
  • Conference abstract and trial registration only

  • Stopped early (aimed for 534 babies) because of a difference in mortality and IVH.

  • Ony entered data on: blood transfusions, Hb, blindness and cerebral palsy.

  • There were 8 deaths reported but no information as to which group they were allocated.

  • Severe IVH was assessed but we have no data that we can use.

  • Neurodevelopmental disabilities were reported at 18 months as: quote:"Proportion of level 0 in Gross Motor Function Classification System in the UCM group was higher in the ICC group (91.9% vs. 71.4%, p=0.005) No differences were found in mean developmental quotient(DQ) using the Kyoto Scale of Psychological Development test between two groups (86.8±16.6 vs. 85.7±16.5, p=0.51). However, incidence of DQ < 70 in the UCM group was lower than in the ICC group (12.6% vs. 20.9%, p=0.046). No infants with hearing impairment or visual impairment were found in the two groups".

  • We wrote to the authors for the data on mortality and IVH (they report a significant difference) and we are awaiting a response.

Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Unclear risk No information
Allocation concealment (selection bias) Unclear risk No information
Blinding of participants and personnel (performance bias) 
 All outcomes High risk Open – no one is blinded
Blinding of outcome assessment (detection bias) 
 All outcomes Unclear risk No information
Incomplete outcome data (attrition bias) 
 All outcomes High risk 203 women recruited but outcomes on 154 only – lost 24%. Also planned to recruit 534 on power calculation but have stopped recruiting based on interim analysis.
Selective reporting (reporting bias) High risk There are many outcomes listed in the trial registration form which are not reported on in the conference abstract. Hopefully they will be reported in the full paper.
Other bias High risk Study quote:“terminated before completion of its planned recruitment of 534 patients based on interim analysis.” Also, conference abstract only so very little information to assess other biases.