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EFFECTIVENESS OF EARLY ORAL REHABILITATION IN INFANTS AFTER SURGERY FOR CONGENITAL HEART DISEASE

Effectiveness of Early Feeding and Swallowing Rehabilitation in Infants With Established Preoperative Oral Feeding After STAT Category 3-5 Congenital Heart Surgery: A Single-Center Before-and-After Study

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-jRCT1030250861
Enrollment
43
Registered
2026-03-31
Start date
2025-10-16
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

congenital heart disease Heart Defects, Congenital

Interventions

Eligible participants will receive an early feeding and swallowing rehabilitation protocol from postoperative day 1 until the earlier of re-establishment of oral feeding or ICU discharge. The interven
otherwise, indirect swallowing training alone will be continued. Feeding screening will be repeated daily until direct swallowing training is started.
Rehabilitation

Sponsors

Tsubokura Shin
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: Patients diagnosed with congenital heart disease by echocardiography performed by a pediatric cardiologist. Patients scheduled to undergo cardiac surgery classified as STAT mortality category 3 to 5. Patients aged 1 month or older and younger than 12 months at the time of surgery. Patients with established preoperative oral feeding of at least 50 kcal/kg/day without supplemental tube feeding or parenteral nutrition. Patients admitted to the PICU for postoperative management after surgery. Patients whose legally authorized representative provides informed consent.

Exclusion criteria

Exclusion criteria: Patients who do not undergo cardiopulmonary bypass during surgery. Patients receiving supplemental tube feeding or parenteral nutrition preoperatively. Patients with cleft lip and/or cleft palate.

Design outcomes

Primary

MeasureTime frame
duration from surgery to the re-establishment of oral feeding

Secondary

MeasureTime frame
duration from surgery to hospital discharge

Contacts

Public ContactShin Tsubokura

National Center for Child Health and Development

tsubokura-s@ncchd.go.jp+81-3-3416-0181

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026