NCT07686029 Use of Maltodextrins in the ERAS Preoperative Fasting Protocol in Pediatric Surgery
| NCT ID | NCT07686029 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Azienda Ospedaliera SS. Antonio e Biagio e Cesare Arrigo di Alessandria |
| Condition | Preoperative Care |
| Study Type | INTERVENTIONAL |
| Enrollment | 200 participants |
| Start Date | 2025-09-03 |
| Primary Completion | 2027-05 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 200 participants in total. It began in 2025-09-03 with a primary completion date of 2027-05.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
This monocentric prospective randomized controlled pilot study aims to evaluate the effectiveness of preoperative maltodextrin administration within an Enhanced Recovery After Surgery (ERAS) protocol in pediatric surgical patients. Children aged 3 to 8 years undergoing elective day surgery will be randomized 1:1 to receive either a maltodextrin-containing clear liquid or a non-sugared clear liquid before surgery. The study will assess preoperative anxiety, patient compliance, parental anxiety, oxidative stress markers, postoperative feeding tolerance, and postoperative recovery outcomes.
Eligibility Criteria
Inclusion Criteria: * Pediatric patients aged 3 to 17 years * Patients undergoing elective surgery in a day surgery setting * Surgical procedure duration less than 60 minutes * Written informed consent signed by a parent or legal guardian Exclusion Criteria: * Maltodextrin intake within 3 hours before surgery * Allergy or intolerance to maltodextrins * Diabetes mellitus or other metabolic disorders potentially affecting study variables * Inadequate nutritional status based on body mass index (BMI) * Absence of signed informed consent by parent or legal guardian
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07686029 clinical trial?
This trial is open to participants of all sexes, aged 3 Years or older, up to 17 Years, studying Preoperative Care. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07686029 currently recruiting?
Yes, NCT07686029 is actively recruiting participants. Contact the research team at clinicaltrialcenter@ospedale.al.it for enrollment information.
Where is the NCT07686029 trial being conducted?
This trial is being conducted at Alessandria, Italy.
Who is sponsoring the NCT07686029 clinical trial?
NCT07686029 is sponsored by Azienda Ospedaliera SS. Antonio e Biagio e Cesare Arrigo di Alessandria. The trial plans to enroll 200 participants.