A prospective, single-center, non-randomized clinical trial evaluating the safety and efficacy of an intermittent suction device in the management of long-gap esophageal atresia in neonates.

Management of Long-Gap Esophageal Atresia Using an Intermittent Suction Device

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

IRCT

Registry ID

IRCT20180310039030N5

Enrollment

Registered

2026-02-05

Start date

2026-02-11

Completion date

Unknown

Last updated

2026-06-01

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

Conditions

Long-Gap Esophageal Atresia. Atresia of esophagus with tracheo-esophageal fistula

Interventions

Intervention group: Neonates diagnosed with long-gap esophageal atresia, defined as an inter-segmental distance exceeding two to three vertebrae, undergo management using a specifically designed inter

Eligibility

Sex/Gender

All

Age

1 Days to 180 Days

Inclusion criteria

Inclusion criteria: Neonates diagnosed with Long-Gap Esophageal Atresia (LGEA) with a gap exceeding 2-3 vertebrae. Age less than 30 days post-birth. Absence of severe concomitant congenital anomalies precluding surgical intervention. Informed consent obtained from parents/guardians.

Exclusion criteria

Exclusion criteria: Severe congenital heart defects requiring urgent surgery. Advanced renal or hepatic insufficiency. Birth weight <1500 g. Active systemic infections. Known chromosomal anomalies.

Design outcomes

Primary

Measure	Time frame
Successful delayed primary esophageal anastomosis, defined as restoration of complete esophageal continuity without clinically significant anastomotic leakage or stricture within six months postoperatively. Timepoint: The primary outcome is assessed at the time of delayed primary esophageal anastomosis and subsequently during postoperative follow-up at 1, 3, and 6 months for anastomotic integrity, leakage, or stricture. Method of measurement: The primary outcome is measured through clinical evaluation, contrast esophagography using water-soluble contrast to detect anastomotic leakage, and esophageal endoscopy when anastomotic stricture is clinically suspected.	—

Measure

Time frame

Successful delayed primary esophageal anastomosis, defined as restoration of complete esophageal continuity without clinically significant anastomotic leakage or stricture within six months postoperatively. Timepoint: The primary outcome is assessed at the time of delayed primary esophageal anastomosis and subsequently during postoperative follow-up at 1, 3, and 6 months for anastomotic integrity, leakage, or stricture. Method of measurement: The primary outcome is measured through clinical evaluation, contrast esophagography using water-soluble contrast to detect anastomotic leakage, and esophageal endoscopy when anastomotic stricture is clinically suspected.

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Secondary

Measure	Time frame
Time to full oral feeding, defined as the number of days from delayed primary esophageal anastomosis until achievement of complete oral feeding without the need for tube feeding. Timepoint: The secondary outcome is measured starting from the time of delayed primary esophageal anastomosis and is recorded continuously until the neonate achieves full oral feeding without the need for tube feeding. Method of measurement: The secondary outcome is measured through daily clinical documentation of the neonate’s feeding status in medical records, calculating the number of days from delayed primary esophageal anastomosis until achievement of full oral feeding without the need for tube feeding.	—

Measure

Time frame

Time to full oral feeding, defined as the number of days from delayed primary esophageal anastomosis until achievement of complete oral feeding without the need for tube feeding. Timepoint: The secondary outcome is measured starting from the time of delayed primary esophageal anastomosis and is recorded continuously until the neonate achieves full oral feeding without the need for tube feeding. Method of measurement: The secondary outcome is measured through daily clinical documentation of the neonate’s feeding status in medical records, calculating the number of days from delayed primary esophageal anastomosis until achievement of full oral feeding without the need for tube feeding.

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Countries

Iran (Islamic Republic of)

Contacts

Public ContactKhashayar Atqiaee

Mashhad University of Medical Sciences

khashayar_atqiaee@sbmu.ac.ir+98 51 3841 1538

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Jun 11, 2026