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Routine versus no assessment of gastric residual volume in preterm infants and time to reach full feeds

Routine versus no assessment of gastric residual volume in preterm infants and time to reach full feeds: A randomized controlled trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2021/01/030628
Enrollment
126
Registered
2021-01-20
Start date
Unknown
Completion date
Unknown
Last updated
2021-11-24

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

Conditions

Health Condition 1: P073- Preterm [premature] newborn [other]

Interventions

Intervention1: Gastric residual volume: Only 0.5 ml of gastric residual volume will be aspirated before each feed. Control Intervention1: Gastric residual volume: Routine aspiration of gastric residua

Sponsors

SMGS Hospital GMC Jammu
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1.Tube fed preterm infants. 2.Gestational age 3.Enrolled within 48 hours of birth.

Exclusion criteria

Exclusion criteria: 1.Major congenital malformations. 2.Interventricular haemorrhage. 3.Antenatal USG documented REDF (reversed end-diastolic flow) and AEDF (Absent end-diastolic flow). 4.Severe birth asphyxia. (APGAR score 5.Infants with invasive ventilatory support. 6.Requirement of vasopressor support to maintain blood pressure at the time of initiation of feeds. 7.Infants requiring venous or arterial umbilical catheterization at the time of enrolment into the study. 8.Infants not fit for enteral nutrition (abdominal distension, vomiting, poor or exaggerated bowel sounds, gastrointestinal bleeding). 9.Respiratory distress (respiratory rate >60 per minute at the time of initiation of feeds and enrolment). Infants were enrolled and feeds initiated only after subsidence of respiratory distress. Respiratory distress lasting more than 5 days was however, an absolute exclusion criterion.

Design outcomes

Primary

MeasureTime frame
Time taken to reach full enteral feedings (180mL/kg/day) in two groups.Timepoint: Day on which full feeds is attained.—

Secondary

MeasureTime frame
Anthropometry.Timepoint: At time of discharge.;Duration of intravenous fluids.Timepoint: Till discharge.;Hemoglobin levels.Timepoint: At time of discharge.;Incidence of necrotizing enterocolitis.Timepoint: Till discharge.;Incidence of osteopenia.Timepoint: Till discharge.;Incidence of ROP.Timepoint: Till discharge.;Incidence of sepsis.Timepoint: Till discharge.;Number of deaths.Timepoint: Till discharge.;Number of episodes of feeding intolerance in two groups.Timepoint: Till discharge.;Number of infants requiring blood transfusion.Timepoint: Till discharge.;Time to regain birth weight.Timepoint: Day on which birth weight is attained.—

Countries

India

Contacts

Public ContactDr Tabish Yaseen

SMGS, Government Medical College, Jammu

bhatti.anuj@gmail.com919419221115

Outcome results

None listed

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