Effect of Oral Insulin on Time to Reach Full Enteral Feeding in Preterm Infants less than 32 weeks of gestation and less than 1250 gram: A randomised controlled trial

Effect of Enteral Insulin on Time to Reach Full Enteral Feeding in Preterm Infants = 32 weeks and = 1250 grams: A Randomised Controlled Trial - NIL

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2024/05/067912

Enrollment

116

Registered

2024-05-27

Start date

Unknown

Completion date

Unknown

Last updated

2024-06-24

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

Conditions

None listed

Interventions

Intervention1: Insulin: Everyday NICU Incharge will prepare a stock solution of insulin in 10 ml syringe by diltuing 1ml of regular insulin solution with 9 ml normal saline making strength of 4 units/

Eligibility

Inclusion criteria

Inclusion criteria: preterm infants = 32 weeks of gestation and = 1250 gram in whom enteral feed is being initiated

Exclusion criteria

Exclusion criteria: gestational age less than 26 weeks or birth weight less than 500 gram suspected GI malformations maternal diabetes hypoglycemia requiring glucose administration of more than 12mg/kg/min in first 72 hours of life failure to obtain consent

Design outcomes

Primary

Measure	Time frame
Time to reach full enteral feeding defined as total enteral intake of 180 ml/kg/day tolerated for 48 hoursTimepoint: Day of life when baby reaches feeds to 180 ml/kg/day which baby has tolerated for 48 hours	—

Secondary

Measure	Time frame
Time taken to reach enteral intake of 100 ml/kg/day tolerated for 48 hours Duration of parenteral nutrition Episodes of feeding intolerance Duration of NPO hours Time taken to regain birth weight Incidence of culture positive sepsis Incidence of necrotising enterocolitis stage 2 or more Episodes of hypoglycemia Growth velocity at stoppage of intervention & at discharge Change in z scores from birth till stoppage of intervention & at discharge for weight length & head circumference Duration of hospital stay All cause mortalityTimepoint: Day of life when baby reaches feeds of 100ml/kg/day tolerated for 48 hours At discharge	—

Measure

Time frame

Time taken to reach enteral intake of 100 ml/kg/day tolerated for 48 hours Duration of parenteral nutrition Episodes of feeding intolerance Duration of NPO hours Time taken to regain birth weight Incidence of culture positive sepsis Incidence of necrotising enterocolitis stage 2 or more Episodes of hypoglycemia Growth velocity at stoppage of intervention & at discharge Change in z scores from birth till stoppage of intervention & at discharge for weight length & head circumference Duration of hospital stay All cause mortalityTimepoint: Day of life when baby reaches feeds of 100ml/kg/day tolerated for 48 hours At discharge

—

Countries

India

Contacts

Public ContactMadhuri Jhanwar

Sir Gangaram Hospital, NewDelhi

drneelamkler@gmail.com9811047391

Outcome results