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ERAS Protocol in Newborns: CARES Study

ConditionPediatric
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age1-28
SponsorIzmir Katip Celebi University

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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

Treatment groups

42 Participants
are divided into 2 treatment groups
Group A: CONTROL GROUPNo intervention 0 interventions
Group B: ERAS GROUPExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Length of Stay

Time from surgery to discharge

Time frame
14 days
2

full feed

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

Time frame
through study completion, an average of 14 days
3

first oral feeding

time until first oral feeding

Time frame
through study completion, an average of 14 days
4

first stool

time until first stool

Time frame
through study completion, an average of 14 days

Secondary outcomes

1

the Accordion Severity Grading System of Surgical Complications Score

It was developed in 2009. In this scoring, the frequency of complications is evaluated under the sub-headings of mild complications, moderate complications, severe complications requiring intervention with or without anaesthesia, organ system failure or death

Time frame
14 days

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Izmir Katip Celebi University

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: