臨床研究等提出・公開システム

Japanese

Date of registration	Mar. 31, 2026
Last modified on	Mar. 31, 2026
Trial ID	jRCT1030250861

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

Contact for Scientific Queries	Name	Tsubokura Shin
	Affiliation	National Center for Child Health and Development
	Address	2-10-1 Okura,Setagaya-ku,Tokyo
	Telephone	+81-3-3416-0181
	E-mail	tsubokura-s@ncchd.go.jp
Contact for Public Queries	Name	Tsubokura Shin
	Affiliation	National Center for Child Health and Development
	Address	2-10-1 Okura,Setagaya-ku,Tokyo
	Telephone	+81-3-3416-0181
	E-mail	tsubokura-s@ncchd.go.jp

Recruitment status	Recruiting

Anticipated date of first enrollment		Aug. 13, 2025
Actual date of first enrollment		Oct. 16, 2025
Target sample size		43
Study Type		Interventional
Study Design	allocation	non-randomized controlled trial
	masking	open(masking not used)
	control	historical control
	assignment	parallel assignment
	purpose	prevention purpose
Key inclusion & exclusion 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	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.
	Age Minimum	0age 1month old over
	Age Maximum	1age 0month old not
	Gender	Both
Health Condition(s) or Problem(s) Studied		congenital heart disease
Intervention(s)		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 intervention will be performed daily only when the attending physician judges the patient to be clinically stable. It will be delivered by a speech-language-hearing therapist or a trained ICU nurse. While the patient is intubated, or remains nil by mouth after extubation, indirect swallowing training using the Vangede method will be performed for 5 minutes twice daily. After extubation, feeding screening will be conducted. If the patient can safely feed on 5 mL of milk, direct swallowing training will be added; otherwise, indirect swallowing training alone will be continued. Feeding screening will be repeated daily until direct swallowing training is started.
Health Condition(s) Keyword		Heart Defects, Congenital
Intervention(s) Keyword		Rehabilitation
Health Condition(s) Code		D006330
Intervention(s) Code		D012046
Primary Outcome(s)		duration from surgery to the re-establishment of oral feeding
Secondary Outcome(s)		duration from surgery to hospital discharge

Source of Monetary Support	National Center for Child Health and Development

Name of Certified Review Board	Certified Clinical Research Review Committee, National Center for Child Health and Development
Address	2-10-1 Okura,Setagaya-ku,Tokyo , Tokyo
Telephone	+81-3-3416-0181
E-Mail	rinken@ncchd.go.jp
Approval Status	Approval
Date of approval	Aug. 13, 2025

Plan to share IPD	No

Countries of Recruitment（Except Japan）	none