Skip to main content
Clinical Trials/CTRI/2024/03/064398
CTRI/2024/03/064398
Not yet recruiting
Not Applicable

Saline Enema versus No Enema to Promote Enteral Feeding in Preterm Infants: A Randomized Controlled Trial

Apollo BGS hospital1 site in 1 country36 target enrollmentStarted: March 29, 2024Last updated:

Overview

Phase
Not Applicable
Status
Not yet recruiting
Sponsor
Apollo BGS hospital
Enrollment
36
Locations
1
Primary Endpoint
To determine time to full enteral feeds.

Overview

Brief Summary

Establishment of enteral nutrition is a significant challenge for premature infants in the neonatal intensive care unit. It is mainly due to delayed gastric emptying, uncoordinated forward propulsive mechanism and increased susceptibility of the gastrointestinal neuronal system to noxious stimulus such as sepsis, acidosis or hypoxia leading to disruption in control of peristalsis. This leads to development of feed intolerance and delay in establishing adequate enteral feeds. Various strategies have been tried to improve feed intolerance which include trophic feeds, use of prokinetics, early meconium evacuation. Our study has an objective of comparing the efficacy of saline enema versus no enema for early meconium evacuation in preterm very low birth weight infants on time to achieve full enteral feeds.

Study Design

Study Type
Interventional
Allocation
Randomized
Masking
Investigator Blinded

Eligibility Criteria

Ages
0.00 Day(s) to 1.00 Day(s) (—)
Sex
All

Inclusion Criteria

  • Preterm with gestational age 28-32 weeks Admission to NICU with in 24hrs after birth.

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

To determine time to full enteral feeds.

Time Frame: Time to achieve full feeds. Can vary from patients to patients.

Secondary Outcomes

  • Duration of NICU stay.(Incidence of feed intolerance.)

Investigators

Sponsor
Apollo BGS hospital
Sponsor Class
Private hospital/clinic
Responsible Party
Principal Investigator
Principal Investigator

Manjesh J

Apollo BGS Hospital

Study Sites (1)

Loading locations...

Similar Trials