To study the effect of use of prophylactic Glycerin enema versus Glycerin suppository versus no intervention on time required to reach full feeds in very low birth weight neonates

An open-label randomized controlled trial to compare the time to reach full enteral feeds between the use of prophylactic Glycerin enema and Glycerin suppository and standard of care in neonates less than 1500 grams at birth - NIL

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2024/07/070434

Enrollment

112

Registered

2024-07-10

Start date

Unknown

Completion date

Unknown

Last updated

2024-07-22

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

Conditions

Health Condition 1: PCS-

Interventions

Intervention1: Glycerin enema: 1st arm of neonates will be prophylactically administered glycerin enema using 6 Fr infant feeding tube inserted upto 6 cm in rectum starting at 24 hours of life and mon

Eligibility

Inclusion criteria

Inclusion criteria: neonates admitted to neonatal intensive care unit (NICU) on day-1 of life with birthweight less than 1500 grams at birth.

Exclusion criteria

Exclusion criteria: 1)Congenital anomalies 2)Major surgery within 48 h of birth. 3)Neonate with APGAR less than 7 at 5 minutes of life. 4)Hemodynamically unstable neonate- e.g those requiring inotrope support

Design outcomes

Primary

Measure	Time frame
The time (in days) required to achieve full enteral feeds (enteral feed volume of 150 ml/kg/day for atleast 24 hours) between the use of prophylactic glycerin enema, glycerin suppository with standard of care in neonates less than 1500 grams at birth.Timepoint: The time (in days) required to achieve full enteral feeds (enteral feed volume of 150 ml/kg/day for atleast 24 hours) between the use of prophylactic glycerin enema, glycerin suppository with standard of care in neonates less than 1500 grams at birth.	—

Measure

Time frame

The time (in days) required to achieve full enteral feeds (enteral feed volume of 150 ml/kg/day for atleast 24 hours) between the use of prophylactic glycerin enema, glycerin suppository with standard of care in neonates less than 1500 grams at birth.Timepoint: The time (in days) required to achieve full enteral feeds (enteral feed volume of 150 ml/kg/day for atleast 24 hours) between the use of prophylactic glycerin enema, glycerin suppository with standard of care in neonates less than 1500 grams at birth.

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Secondary

Measure	Time frame
1)To compare time required to regain birth weight between the use of prophylactic glycerin enema, glycerin suppository with standard of care in neonates less than 1500 grams at birth. 2)To compare adverse events like feeding intolerance, necrotizing enterocolitis (Modified Bell’s classification) between the use of prophylactic glycerin enema, glycerin suppository with standard of care in neonates less than 1500 grams at birth. 3)To compare age at the time of discharge from hospital between the use of prophylactic glycerin enema, glycerin suppository with standard of care in neonates less than 1500 grams at birth.Timepoint: 1)time required to regain birth weight 2) time till discharge from NICU 3)time till discharge from NICU	—

Measure

Time frame

1)To compare time required to regain birth weight between the use of prophylactic glycerin enema, glycerin suppository with standard of care in neonates less than 1500 grams at birth. 2)To compare adverse events like feeding intolerance, necrotizing enterocolitis (Modified Bell’s classification) between the use of prophylactic glycerin enema, glycerin suppository with standard of care in neonates less than 1500 grams at birth. 3)To compare age at the time of discharge from hospital between the use of prophylactic glycerin enema, glycerin suppository with standard of care in neonates less than 1500 grams at birth.Timepoint: 1)time required to regain birth weight 2) time till discharge from NICU 3)time till discharge from NICU

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Countries

India

Contacts

Public ContactPrasoon Bansal

Bharati Vidyapeeth Deemed University Medical College, Pune

malshenandini@gmail.com9822850716

Outcome results

None listed

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