LISA vs INSURE in the Treatment of Respiratory Distress Syndrome in Preterm Infants

Summary

To evaluate the efficacy of less invasive surfactant administration（LISA ）technique in the treatment of neonatal respiratory distress syndrome（NRDS） by comparing with the traditional Intubate-Surfactant-Extubate（INSURE） technique.

Conditions

• Preterm Infants

Interventions

PROCEDURE

Intubate-Surfactant-Extubate(INSURE)

Infants are given an endotracheal intubation, with manual lung inflation in order to keep the oxygen supply，and the surfactant(kelisu,China Resources Shuanghe Pharmaceutical) was slowly instilled into the airway through the tracheal tube, and the tracheal tube was removed for non-invasive NCPAP(nasal continuous positive airway pressure)-assisted breathing.

PROCEDURE

less invasive surfactant administration(LISA)

Infants are spontaneously breathing with nasal CPAP(continuous positive airway pressure) support without manual lung inflation and surfactant(kelisu,China Resources Shuanghe Pharmaceutical) is administered through vocal cords via a smaller catheter.

Sponsors & Collaborators

• The First Affiliated Hospital of University of Science and Technology of China

  collaborator OTHER

• The First Affiliated Hospital of Bengbu Medical University

  collaborator OTHER

• Second Affiliated Hospital of Bengbu Medical College

  collaborator OTHER

• Fuyang people's hospital

  collaborator OTHER

• lixin people's hospital

  collaborator UNKNOWN

• The Third People's Hospital of Bengbu

  collaborator OTHER_GOV

• Huaibei coal general hospital

  collaborator UNKNOWN

• Bozhou people's hospital

  collaborator UNKNOWN

• Luan people's hospital

  collaborator UNKNOWN

• Huaibei maternal and child health hospital

  collaborator UNKNOWN

• Huainan maternal and child health hospital

  collaborator UNKNOWN

• Chizhou people's hospital

  collaborator UNKNOWN

• Xuancheng people's hospital

  collaborator UNKNOWN

• First Affiliated Hospital of Wannan Medical College

  collaborator OTHER

• Tongling People's Hospital

  collaborator OTHER_GOV

• Maanshan maternity and child care

  collaborator UNKNOWN

• Wuhu first people's hospital

  collaborator UNKNOWN

• Anqing Municipal Hospital

  collaborator OTHER

• Anhui Provincial Hospital

  lead OTHER_GOV

Principal Investigators

• Pan jiahua, PhD · Director of pediatric department of the First Affiliated Hospital of University of Science and Technology of China

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

25 Weeks

Max Age

32 Weeks

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2020-01-01

Primary Completion

2024-12-31

Completion

2024-12-31