Effect of full feeding versus increasing feed volumes in growth restricted infants less than 1500 grams with abnormal antenatal doppler in umbilical artery on the duration of hospital stay

Phase 3

• Conditions: Health Condition 1: K00-K95- Diseases of the digestive system

• Registration Number: CTRI/2023/11/059665
• Lead Sponsor: I

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 13 November 2023

Recruitment & Eligibility

• Status: ot Yet Recruiting
• Sex: Not specified
• Target Recruitment: 0

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.

 vi) BP (blood pressure ) , normal as per normograms.

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified