Delayed cord clamping in Rh-isoimmunised infants: an open labelled randomised control trial
Not Applicable
Completed
- Conditions
- Health Condition 1: O- Medical and SurgicalHealth Condition 2: null- Rh isoimmunised infants with more that 28weeks 0days gestation to 41weeks days gestation
- Registration Number
- CTRI/2016/12/007592
- Lead Sponsor
- AIIMS
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 70
Inclusion Criteria
Rh isoimmunised infants at time of birth from 28wks 0 days to 41 weeks 6 days willing for follow up till 12weeks postnatal age
Exclusion Criteria
1.Babies with major congenital anomalies
2.Rh isoimmunised babies born to Retro positive mother
3.Babies born with significant antepartum hemorrhage due to causes like abruptio placentae (significant antepartum bleed into placenta after separation of decidua), cord prolapsed ( protrusion of cord along with or ahead of delivery of baby) and cord anomalies like true knot all of which are associated with significant peripartum asphyxia and need immediate resuscitation
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method To measure Packed cell volume within 2(±1)hr of birth, in Rh isoimmunised infants randomised to early cord clamping group or late cord clamping group, with gestation age more than 28weeks and 0 days to 41weeks and 6 daysTimepoint: To measure Packed cell volume within 2(±1)hr of birth, in Rh isoimmunised infants randomised to early cord clamping group or late cord clamping group, with gestation age more than 28weeks and 0 days to 41weeks and 6 days
- Secondary Outcome Measures
Name Time Method Echocardiographic evidence of fluid overload and hemodynamic compromiseTimepoint: once at 8-16hours of age(mean at 12hours.;Incidence of blood transfusion in initial 12weeks (±2) weeksof age inRh isoimmunised infantsTimepoint: Blood transfusion done as per unit protocol cutoffs).After discharge will be assessed at wk,6wk, 10 week of age with variation of 2 wks at each visit;Number of babies undergoing double volume exchange transfusion( DVET)Timepoint: at time of discharge;Number of babies undergoing partial exchange transfusion (PET)Timepoint: at birth, using as per unit protocol;Total duration of phototherapy(PT)Timepoint: At time of discharge