A Randomized Controlled Trial Comparing Neurally Adjusted Ventilatory Assist (NAVA) with Synchronized Intermittent Mandatory Ventilation (SIMV+PS) in Preterm Infants with Respiratory Distress Syndrome (RDS)

A Randomized Controlled Trial Comparing Neurally Adjusted Ventilatory Assist (NAVA) with Synchronized Intermittent Mandatory Ventilation (SIMV+PS) in Preterm Infants Born at 26-31 Weeks of Gestation with Respiratory Distress Syndrome (RDS) - A RCT comparing NAVA with SIMV+PS in preterm born at 26-31 weeks of GA with RDS

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000055670

Enrollment

Registered

2024-10-01

Start date

2024-10-01

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

A neonate born between 26 weeks 0 days and 31 weeks 6 days of gestation, admitted to our neonatal intensive care unit from October 1, 2024, to September 30, 2025, with a diagnosis of respiratory distress syndrome

Interventions

SIMV and PS:Initial Settings,Weaning,and Extubation Criteria are the same as standard clinical practice.Initial Settings:Peak Inspiratory Pressure(PIP):20cmH2O,Positive End-Expiratory Pressure(PEEP):5

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Preterm infants diagnosed with respiratory distress syndrome between 26 weeks and 0 days and 31 weeks and 6 days of gestation. Neonates diagnosed with respiratory distress syndrome. The diagnosis is made if any of the following criteria are met: Microbubble test (diagnostic criteria of Chida): Fewer than 5 microbubbles/mm2 in the amniotic fluid, or Fewer than 10 microbubbles/mm2 in the gastric aspirate. Chest X-ray (Bomsel classification): The presence of any of the following findings: reticulogranular pattern, ground-glass opacity, bronchial air column, or white-out appearance. Symptoms: The presence of tachypnea, nasal flaring, grunting, retractions, or cyanosis. Infants born between Octorber 1, 2024, and September 30, 2025. Infants for parental (proxy) consent for research participation was obtained within 23 hours post-birth. Includes both neonates born within this hospital and those born at other hospitals.

Exclusion criteria

Exclusion criteria: Cases of tracheomalacia, bronchomalacia, and pulmonary hypoplasia. Cases of congenital gastrointestinal diseases such as esophageal atresia and small bowel atresia. Cases of chromosomal abnormalities, neuromuscular diseases, and congenital heart diseases. Cases where the umbilical artery blood pH at birth or the initial blood gas pH of the patient was less than 7.0. Cases where it was not possible to explain the randomized controlled trial within 23 hours of birth, and the assigned respiratory support could not be used within 24 hours of birth. Cases who are deemed inappropriate by the physician.

Design outcomes

Primary

Measure	Time frame
Duration of endotracheal intubation	—

Secondary

Measure	Time frame
hospitalization period in NICU,hospitalization period, weight gain rate, age at achieving enteral nutrition (WQ100) and age at achieving full enteral nutrition.	—

Countries

Japan

Contacts

Public ContactTomonori Kurimoto

Kagoshima City Hospital neonatology

maron.n.tomo.o@gmail.com81-99-230-7000

Outcome results

None listed

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