CTRI/2023/11/059665
Not yet recruiting
Phase 3
Effect of total enteral feeding versus incremental feeding in small for gestational age very low birth weight infants with antenatal doppler showing absent or reversed end diastolic flow in umbilical artery on the duration of hospital stay - NI
I0 sites0 target enrollmentTBD
Overview
- Phase
- Phase 3
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- I
- Status
- Not yet recruiting
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\) Intrauterine growth restricted babies with birth weight of 1\-1\.5 kg
- •2\) Antenatal ultrasound showing :
- •a) Absent or Reversed end diastolic flow velocities from umbilical artery on at least one occassion during pregnancies, or
- •b) Ductus venosus PI \= 95 percentile or absent / reversed end diastolic velocity in ductus venosus doppler waveforms.
- •3\) Hemodynamically stable at randomisation, as defined by:
- •i) Heart rate in between 100 to 180 beats/min
- •ii) Respiratory rate in between 40 to 60/min with/ without noninvasive respiratory support.
- •iii) Axillary Temperature in between 36\.5 to 37\.5 ? C
- •iv) Capillary filling time of \< 3sec
- •v) Spo2 (saturation of oxygen) between 90 to 95% with/ without noninvasive respiratory support.
Exclusion Criteria
- •I.Requiring extensive resuscitation at birth
- •II. Major congenital anomalies
- •III.Shock requiring more than two inotropes.
- •IV.Needing invasive ventilation
- •V.Any medical/ surgical conditions that precludes feeding
- •VI.Babies with altered / bilious aspirates at the time of recruitment.
- •VII.Metabolic derangements like symptomatic hypoglycaemia that precludes feeding
- •VIII.Refusal of consent
Outcomes
Primary Outcomes
Not specified
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