ERAS Protocol in Newborns: CARES Study

NCT05511233 | Not Yet Recruiting

• 1 other identifier: 2022
• Study Type: interventional
• Target: 42
• Locations: 0 countries
• Sites: N/A

Brief Summary

Aim: To determine whether the enteral feeding time and the type of the nutrient (according to the ERAS Recommendations) have any effect on LoS, complications, body weight gain, time until oral feeding, and time until first stool who have undergone intestinal surgery. Design: A blinded, retrospective, randomized controlled trial. Setting: One-centred. Participants: Newborns who had intestinal surgery in the Ege University Faculty of Medicine Hospital Neonatal Surgery Intensive Care Unit and whose records can be accessed retrospectively from the electronic health records will be included. Those whose early enteral feeding initiation is contraindicated will not be included in the study.

Conditions

Pediatric

Keywords

pediatric surgery; enhanced recovery

Outcome Measures

Primary Outcomes (6)

• Length of Stay

  Time from surgery to discharge

  14 days

• full feed

  time until full feed (120 ml/kg/day)

  through study completion, an average of 14 days

• first oral feeding

  time until first oral feeding

  through study completion, an average of 14 days

• first stool

  time until first stool

  through study completion, an average of 14 days

• body weight gain

  body weight gain

  through study completion, an average of 14 days

• feeding intolerance

  abdominal distention and repeated vomiting-more than three times a day

  through study completion, an average of 14 days

Secondary Outcomes (1)

• the Accordion Severity Grading System of Surgical Complications Score

  14 days

Study Arms (2)

CONTROL GROUP

NO INTERVENTION

Control Group: Electronic health records of the newborns who do not receive breast milk in the first 48 hours of the postoperative period will be in the control group.

ERAS GROUP

EXPERIMENTAL

ERAS Group: Electronic health records of the newborns who had breastmilk within the first 48 hours in the postoperative period will be in the ERAS group.

Dietary Supplement: feeding with breastmilk within 48 hours after surgery

Interventions

feeding with breastmilk within 48 hours after surgery DIETARY_SUPPLEMENT

Electronic health records of babies who feed and not fed with breastmilk within 48 hours after surgery

ERAS GROUP

Eligibility Criteria

• Age: 1 Day - 28 Days
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Newborns who had intestinal surgery in the Ege University Faculty of Medicine Hospital Neonatal Surgery Intensive Care Unit and
• whose records can be accessed retrospectively from the electronic health records will be included.

You may not qualify if:

• Those whose early enteral feeding initiation is contraindicated will not be included in the study.

Sponsors & Collaborators

• Izmir Katip Celebi University: lead

MeSH Terms

Interventions

Postoperative Period

Intervention Hierarchy (Ancestors)

Perioperative Period; Surgical Procedures, Operative; Patient Care; Health Services; Health Care Facilities Workforce and Services

Study Officials

• Esra ARDAHAN AKGÜL, Asst. Prof.

  İzmir Katip Çelebi University

  STUDY CHAIR

Central Study Contacts

Esra ARDAHAN AKGÜL, Asst. Prof.

CONTACT

+00902323293535; esra.ardahan@ikcu.edu.tr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor, Principal Investigator

Study Record Dates

• First Submitted: August 2, 2022
• First Posted: August 22, 2022
• Study Start: November 1, 2024
• Primary Completion: April 1, 2025
• Study Completion: September 30, 2025
• Last Updated: October 23, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share