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Clinical Trials/CTRI/2023/11/059665
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.

Registry
who.int
Start Date
TBD
End Date
TBD
Last Updated
2 years ago
Study Type
Interventional

Investigators

Sponsor
I

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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