Intratracheal PS through old and new catheters in mechanically ventilated NRDS children: a randomized controlled trial study protocol

Status

Active, not recruiting

Phases

Early Phase 1

Study type

Interventional

Source

ChiCTR

Registry ID

ChiCTR2300076353

Enrollment

Unknown

Registered

2023-10-07

Start date

2024-01-01

Completion date

Unknown

Last updated

2023-10-09

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

Conditions

Neonatal respiratory distress syndrome

Interventions

experimental group:Intratracheal PS administration through a new tracheal catheter in mechanically ventilated NRDS children

control group:Intratracheal PS administration through traditional tracheal catheters in mechanically ventilated NRDS children

Eligibility

Sex/Gender

All

Age

No minimum to 0.1 Years

Inclusion criteria

Inclusion criteria: ? Newborns born less than 24 hours old Diagnosed as NRDS. ? I am about to undergo the first endotracheal intubation and mechanical ventilation after birth. When facing any of the following situations, respiratory support with mechanical ventilation for infants will be considered: A. Severe respiratory acidosis lasting for more than 2 hours (PaCO2>60mmHg, pH0.5, PaO2<50mmHg or SpO2<85%). C. Frequent apnea (more than 3 episodes per hour, requiring ventilation with airbags and masks) accompanied by bradycardia (heart rate less than 100 beats per minute), D. Clinical emergency.

Exclusion criteria

Exclusion criteria: ? Congenital malformations with life-threatening conditions or congenital abnormalities that affect respiratory function; ? Level 3 or 4 intraventricular hemorrhage (IVH); ? Before inclusion, received endotracheal intubation or any form of surfactant therapy for any reason; ? Transferred out of the neonatal intensive care unit before randomization; ? Without written informed consent signed by the guardian; ? Surgery is necessary

Design outcomes

Primary

Measure	Time frame
Mechanical ventilation duration;	—

Secondary

Measure	Time frame
The total number of endotracheal intubations and the time required for each intubation;The diameter and insertion depth of tracheal catheters;The lowest SpO2 and heart rate during endotracheal intubation and surfactant administration.;	—

Countries

China

Contacts

Public ContactChuangfeng Li

Qujing Maternal and Child Health Hospital in Yunnan Province

1060318663@qq.com+86 139 8897 0311

Outcome results

None listed

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