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

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 - NIL

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2023/11/059665

Enrollment

Registered

2023-11-08

Start date

Unknown

Completion date

Unknown

Last updated

2023-11-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Interventions

Intervention1: EARLY TOTAL ENTERAL FEED: The infants will be started with MEN (minimal enteral nutrition ) and total parenteral nutrition at birth . At the end of 48 hours they will be randomized into

Eligibility

Inclusion 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 v) Spo2 (saturation of oxygen) between 90 to 95% with/ without noninvasive respiratory support. vi) BP (blood pressure ) , normal as per normograms.

Exclusion criteria

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

Design outcomes

Primary

Measure	Time frame
To compare the duration of hospital stay in babies enrolled in both the groups.Timepoint: At discharge	—

Secondary

Measure	Time frame
1.Time taken to achieve 150 ml/kg/d of feed and maintained for three consecutive days. 2.Time to regain birth weight in days 3. Number of babies with culture positive sepsis until hospital discharge. 4.Incidence of ROP (Retinopathy of prematurity) requiring treatment. 5.Number of episodes of Hypoglycemia 6.Number of episodes of feed intolerance 7.Incidence of NEC (Bell’s stage =2) or Spontaneous intestinal perforation any time during hospitalization. 8.MortalityTimepoint: At discharge	—

Measure

Time frame

1.Time taken to achieve 150 ml/kg/d of feed and maintained for three consecutive days. 2.Time to regain birth weight in days 3. Number of babies with culture positive sepsis until hospital discharge. 4.Incidence of ROP (Retinopathy of prematurity) requiring treatment. 5.Number of episodes of Hypoglycemia 6.Number of episodes of feed intolerance 7.Incidence of NEC (Bell’s stage =2) or Spontaneous intestinal perforation any time during hospitalization. 8.MortalityTimepoint: At discharge

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Countries

India

Contacts

Public ContactDr Swati Manerkar

Lokmanya Tilak Municipal Medical College and General Hospital,Sion

drswatimanerkar@gmail.com9769997968

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026