Backes 2016.
Methods | Randomised controlled trial | |
Participants |
Inclusion criteria
Exclusion criteria
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Interventions |
Intervention: DCC
Comparator: ECC
Additional information
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) |
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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
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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. |