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

Ranjit 2015.

Methods Randomised controlled trial
Participants Inclusion criteria
  • Neonates born between 30 0/7 and 36 6/7 weeks of gestation

  • N = 100 babies


Exclusion criteria
  • Mothers with Rhesus negative blood group and monoamniotic – monochorionic twins

Interventions Intervention: DCC
  • Cord was clamped more than 2 mins after the birth of the baby.

  • Until the cord was clamped, the baby was placed covered on the mother’s abdomen in case of vaginal births or on the mother’s thigh in case of CSs.

  • In babies needing resuscitation at birth, immediate cord clamping was practiced irrespective of group allocation.

  • N = 50 babies (6 were excluded because they needed resuscitation) ‐ analysed 44


Comparator: ECC
  • Cord was clamped immediately after birth of the infant, the standard practice at authors’ institution.

  • N = 50 babies


Additional information
  • Gestational subgroup: mixed gestation

  • Resuscitation with cord intact: not available

  • Access to NICU: yes

  • Length of delay: > 2 mins

  • Baby placed: on mother's abdomen at vaginal births and on mother's thigh at caesarean

  • Uterotonic: no information

  • UCM: n/a


Comparison 1
DCC with neonatal resuscitation after cord clamping vs ECC (subgroup by gestation)
Subgroup 3: mixed gestation
Comparison 2
DCC with neonatal resuscitation after cord clamping vs ECC (subgroup by type intervention)
Subgroup 5: DCC at > 2 mins with baby level with uterus and placenta
Outcomes Primary
  • Hct and serum ferritin levels at 6 weeks of age


Secondary
  • Hct on day 1; anaemia, polycythaemia, significant jaundice, duration of phototherapy; need for blood transfusions; PDA; RDS; NEC; transient tachypnoea of newborn (TTNB); sepsis; IVH; hypoglycaemia; apnoea; shock; hypoxic ischaemic encephalopathy (HIE); acute kidney injury (AKI) and death.


Definitions
  • Significant jaundice was defined as need for phototherapy based on AAP 2004 policy statement for babies > 35 weeks (6) and phototherapy guidelines for very low birthweight infants (7).

  • Anemia and polycythaemia on day 1 were defined as Hct < 45% and > 65% respectively.

Notes Setting: tertiary care hospital in South India
Dates: May 2010 to November 2010
Declaration of interest: no conflict of interest.
Trial funding source: quote: "Role of funding source ‐ None"
Further information
  • Reported sepsis and unclear of this is late sepsis, but we used the data.

  • Reported transfusion of packed cells and we used this data under 'Blood transfusion'.

  • Reported exclusive breastfeeding: 100% for DCC and 89.5% for ECC.

  • We are writing to the authors to ask whether any of the 6 babies excluded from the DCC group (because they needed resuscitation) had died. We have included the data on death in out data and analysis.

Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk Qquote: “…based on computer generated random numbers.”
Allocation concealment (selection bias) Low risk Quote: “Allocation concealment was achieved by sequentially numbered opaque sealed envelopes containing the codes for intervention”
Blinding of participants and personnel (performance bias) 
 All outcomes High risk It is not possible to blind clinicians nor women.
Blinding of outcome assessment (detection bias) 
 All outcomes Unclear risk There is no information as to whether there was any attempt to blind outcome assessment.
Incomplete outcome data (attrition bias) 
 All outcomes High risk 6 babies (12%) randomised to DCC group were excluded from the study as they did not receive the intervention due to the need for resuscitation. None were excluded from the ECC group, yet 5 died in the ECC group and no deaths were reported in the DCC group, but there is no information on the 6 who were excluded ‐ it is important to know how many of these died.
4 in the ECC group and 3 in the DCC group were lost for follow‐up.
Total exclusion DCC 9/50 (18%) ICC 4/50 (8%). Overall 13% exclusions, but uneven.
Selective reporting (reporting bias) Unclear risk We did not assess the trial protocol.
Other bias Unclear risk Baseline characteristics were similar but they excluded 6 babies from DCC because they needed resuscitation.