NCT04126382

Brief 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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
200

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Jan 2020

Longer than P75 for phase_2

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 4, 2019

Completed
11 days until next milestone

First Posted

Study publicly available on registry

October 15, 2019

Completed
3 months until next milestone

Study Start

First participant enrolled

January 1, 2020

Completed
5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2024

Completed
Last Updated

October 15, 2019

Status Verified

October 1, 2019

Enrollment Period

5 years

First QC Date

October 4, 2019

Last Update Submit

October 13, 2019

Conditions

Preterm Infants

Keywords

NRDSpreterm infantsLISAINSURE

Outcome Measures

Primary Outcomes (2)

  • Rate of intubation

    The criteria for endotracheal mechanical ventilation were as follows: severe apnea and bradycardia (defined as recurrent apnea with \> 3 episodes per hour associated with heart rate \< 100/min, a single episode of apnea that required bag and mask ventilation), hypoxia (FiO2\>0.6 with PaO2\<50mmHg or TcSO\<0.85), severe respiratory acidosis (PaCO2 \> 60 mmHg with pH\<7.20).

    during the first 3 days after birth

  • The incidence of bronchopulmonary dysplasia

    BPD was diagnosed and classified based on the Practical neonatology 4th edition:Need for O2 supplementation(FiO2\>0.21) for at least 28 days after birth.

    at a post-menstrual age of 36 weeks or at discharge

Secondary Outcomes (12)

  • Effect on of arterial blood gas analysis

    during the whole procedure of surfactant replacement,up to 3 days after birth

  • The Incidence of Patent ductus arteriosus

    during hospitalization, up to 60 days

  • The Incidence of Pneumothorax

    during non-invasive ventilation, up to 30 days

  • The Incidence of Abdominal Distention

    during non-invasive ventilation, up to 30 days

  • The Incidence of Neonatal Necrotizing Enterocolitis(>Stage II)

    during hospitalization, up to 60 days

  • +7 more secondary outcomes

Study Arms (2)

INSURE

ACTIVE COMPARATOR

Intubate-Surfactant-Extubate(INSURE) technique is a Important treatment in premature infants with RDS.

Procedure: Intubate-Surfactant-Extubate(INSURE)

LISA

EXPERIMENTAL

Less invasive surfactant administration(LISA) technique is a Important treatment in premature infants with RDS.

Procedure: less invasive surfactant administration(LISA)

Interventions

Intubate-Surfactant-Extubate(INSURE)PROCEDURE

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.

INSURE
less invasive surfactant administration(LISA)PROCEDURE

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.

LISA

Eligibility Criteria

Age25 Weeks - 32 Weeks
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Gestational age (GA) less than 32 weeks
  • diagnosis of RDS. The diagnosis of RDS will be based on clinical manifestations (Progressive dyspnea, nasal flaring and or grunting), chest X-ray findings and need for noninvasive ventilation support(fraction of inspired oxygen\>40％) in 6 hours after birth
  • informed parental consent has been obtained

You may not qualify if:

  • severe RDS have been treated with endotracheal intubation,surfactant and mechanical ventilation
  • major congenital malformations or complex congenital heart disease
  • Pulmonary hemorrhage
  • Cardiopulmonary failure
  • septicemia, Intraventricular Hemorrhage (IVH, ≥ Grade Ⅲ), and Congenital genetic metabolic disease
  • transferred out of the NICUs(neonatal intensive care units) with surgical treatment or other intervention

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Officials

  • Pan jiahua, PhD

    Director of pediatric department of the First Affiliated Hospital of University of Science and Technology of China

    STUDY DIRECTOR

Central Study Contacts

Zhang Lan, PhD

CONTACT

18256935186moaana@163.com

Pan Jiahua, PhD

CONTACT

13866167758panjiahua1960@163.com

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 4, 2019

First Posted

October 15, 2019

Study Start

January 1, 2020

Primary Completion

December 31, 2024

Study Completion

December 31, 2024

Last Updated

October 15, 2019

Record last verified: 2019-10