The neoGASTRIC trial: Avoiding routine gastric residual volume measurement in neonatal critical care

Not Applicable

• Conditions: Preterm birth; Neonatal Diseases

• Registration Number: ISRCTN16710849
• Lead Sponsor: Imperial College London

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2023-02-08
• Last Update Posted: 3 October 2023
• Study Completion: 2026-10-31

Recruitment & Eligibility

• Status: Ongoing
• Sex: All
• Target Recruitment: 7040

Inclusion Criteria

1. Gestational age at birth less than 34+0 gestational weeks+days
2. Nasogastric or orogastric tube in place
3. Baby receiving less than or equal to 15ml/kg/day of milk

Exclusion Criteria

Current exclusion criteria as of 13/06/2023:

1. Infant has received more than 15ml/kg/day of milk for more than 24 hours
2. Gastrointestinal surgical condition prior to randomisation
3. Major congenital abnormalities
4. No realistic prospect of survival
5. A parent has opted out of infant’s participation in neoGASTRIC

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Previous exclusion criteria:

1. Gastrointestinal surgical condition prior to randomisation
2. Major congenital abnormalities
3. No realistic prospect of survival
4. A parent has opted out of infant’s participation in neoGASTRIC

Study & Design

• Study Type: Other
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
All outcomes will be measured up to discharge home or when the infant reaches 44+0 gestational weeks, whichever is sooner, unless otherwise stated. All data will be collected from infants hospital notes/records.<br>1. neoGASTRIC main trial - superiority outcome<br>Time from birth to reach full milk feeds for 3 consecutive days (at least 145ml/kg/day where this is considered full enteral feeds, or where breastfeeding and any additional milk is considered equivalent to full enteral feeds).<br>Also including,<br>2. neoGASTRIC Process Evaluation primary outcome: to evaluate pilot phase trial processes by analysing parent and staff responses from questionnaires and observing staff practices.<br>3. neoGASTRIC SWAT primary outcome: the parent did not opt out of infant's participation in the trial pre-randomisation.