Routine Versus no Assessment of Gastric Residual Volumes in Preterm Infants

NCT04062851 | Completed DMC

• 1 other identifier: 1255832
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

The practice of checking gastric residuals is not evidence based. The amount of gastric residual volume (GRV) does not correlate with either feeding intolerance or development of NEC. We hypothesize that not monitoring GRV in infants with birth weights \< 1,250 g, and who are being fed intermittently by gastric tube, will result in earlier attainment of full feeding. This is an unblinded randomized controlled trial where GRV will not be checked routinely in the intervention group.

Conditions

Gastric Residual Volume; Preterm Infant; Feeding Disorder Neonatal

Keywords

gastric residuals, feeding, very low birth weight infants

Outcome Measures

Primary Outcomes (1)

• Days to reach full enteral feeds

  Days to reach enteral feeding volume of 120ml/kg/day

  1 month after enrollment

Secondary Outcomes (3)

• Necrotizing enterocolitis

  Until hospital discharge, an average of 2-6 months

• weight gain

  4 weeks chronological age and 36 weeks corrected gestation

• frequency of feeding interruptions

  Until full feeds are reached, usually between 2 weeks - 2 months

Study Arms (2)

GRV group

NO INTERVENTION

Gastric residuals will be checked prior to feeds

NO GRV group

EXPERIMENTAL

Gastric residuals will not be checked prior to feeds

Other: No Gastric residual volume monitoring

Interventions

No Gastric residual volume monitoring OTHER

Gastric residual volumes will not be monitored

NO GRV group

Eligibility Criteria

• Age: 2 Hours - 1 Month
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Birth weight ≤1250g
• Gestational age of \< 33 weeks
• Expected to receive feeds via gastric tubes

You may not qualify if:

• Death expected within 72 hours of birth
• Major chromosomal or congenital anomaly
• Major GI anomaly such as gastroschisis, spontaneous perforation etc.

Sponsors & Collaborators

• AdventHealth: lead

Study Sites (1)

AdventHealth

Orlando, Florida, 32803, United States

Location

Related Publications (3)

• Li YF, Lin HC, Torrazza RM, Parker L, Talaga E, Neu J. Gastric residual evaluation in preterm neonates: a useful monitoring technique or a hindrance? Pediatr Neonatol. 2014 Oct;55(5):335-40. doi: 10.1016/j.pedneo.2014.02.008. Epub 2014 Aug 14.

  PMID: 25129325 RESULT

• Torrazza RM, Parker LA, Li Y, Talaga E, Shuster J, Neu J. The value of routine evaluation of gastric residuals in very low birth weight infants. J Perinatol. 2015 Jan;35(1):57-60. doi: 10.1038/jp.2014.147. Epub 2014 Aug 28.

  PMID: 25166623 RESULT

• Parker L, Torrazza RM, Li Y, Talaga E, Shuster J, Neu J. Aspiration and evaluation of gastric residuals in the neonatal intensive care unit: state of the science. J Perinat Neonatal Nurs. 2015 Jan-Mar;29(1):51-9; quiz E2. doi: 10.1097/JPN.0000000000000080.

  PMID: 25633400 RESULT

MeSH Terms

Conditions

Premature Birth

Condition Hierarchy (Ancestors)

Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Study Officials

• Narendra Dereddy, MD

  AdventHealth

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Unblinded Single center Randomized controlled trial

Study Record Dates

• First Submitted: April 9, 2019
• First Posted: August 20, 2019
• Study Start: May 3, 2019
• Primary Completion: July 26, 2021
• Study Completion: March 31, 2022
• Last Updated: April 26, 2022

Record last verified: 2022-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)