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A randomized controlled study on the treatment of respiratory distress syndrome in premature infants using improved INSURE and MIST techniques

A randomized controlled study on the treatment of respiratory distress syndrome in premature infants using improved INSURE and MIST techniques

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2400094642
Enrollment
Unknown
Registered
2024-12-25
Start date
2025-01-01
Completion date
Unknown
Last updated
2025-01-06

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

Conditions

respiratory distress syndrome

Interventions

improved INSURE:Continue to provide continuous mechanical ventilation for about 1 hour after injecting PS
MIST:After completing the PS administration, remove the tube and withdraw the gastric contents from the gastric tube to understand the reflux of PS into the digestive tract.

Sponsors

Department of Pediatrics , Suining County People ' s Hospital
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: Inclusion criteria Those who meet the following conditions simultaneously: (1) live born newborns with gestational age=30% is required to maintain a transcutaneous pulse oxygen saturation of 90% to 94%;(5) Obtain informed consent from the guardian.

Exclusion criteria

Exclusion criteria: Exclusion criteria: (1) Regular or high-frequency mechanical ventilation is required before enrollment; (2) Vital signs are extremely unstable; (3) Congenital respiratory malformations (such as posterior nasal atresia, cleft palate, tracheoesophageal fistula, etc.); (4) Severe cyanotic congenital heart disease (such as transposition of the great arteries, Tetralogy of Fallot, etc.); (5) Severe congenital malformations (such as Trisomy 21 syndrome, congenital diaphragmatic hernia, omphalocele, etc.)

Design outcomes

Primary

MeasureTime frame
the duration o respiratory support,DRS;

Secondary

MeasureTime frame
Time of first use of pulmonary surfactant;Pulmonary surfactant injection time;Total operating time;Number of times pulmonary surfactant is used;post administration blood gas analysis results;Delay extubation for 1 hour and recheck chest X-ray results;Number of cases of mechanical ventilation with endotracheal intubation within 72 hours;Number of apnea;Time for non-invasive and invasive respiratory support;hemodynamically significant patent ductus arteriosus,hsPDA;Sepsis ;intraventricular hemorrhage,IVH;periventricular leukomalacia,PVL;Airleak syndrome;necrotizing enterocolitis, NEC;bronchopulmonary dysplasia,BPD;retinopathy of premature,ROP;Hospitalization duration and mortality rate;

Countries

China

Contacts

Public ContactTong Shi

Suining County People's Hospital

15862185137@163.com+86 158 6218 5137

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026