Modified Intubation-surfactant-extubation (InSurE) Technique in Preterm Neonates With Respiratory Distress Syndrome

June 19, 2019 updated by: The First Affiliated Hospital with Nanjing Medical University

Application of Modified Intubation-surfactant-extubation (InSurE) Technique in Preterm Neonates With Respiratory Distress Syndrome

This study evaluates the less invasive surfactant administration (LISA) combined with synchronized nasal intermittent positive pressure ventilation (SNIPPV) technique in the treatment of respiratory distress syndrome (RDS) of preterm neonates. The modified InSurE group will receive "LISA + SNIPPV" technique, while the traditional InSurE group will receive the intubation, surfactant, extubation and CPAP technique.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

120

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
      • Nanjing, China, 210029
        • The First Affiliated Hospital of Nanjing Medical University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

No older than 1 year (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. premature infants with birth weight < 2500g and gestational age < 36+6 weeks;
  2. High-risk premature infants with early symptoms of RDS or infants who are diagnosed clinically RDS.
  3. the participating hospital obtained the consent of the Ethics Committee.
  4. parental informed consents were obtained.

Exclusion Criteria:

  1. severe congenital malformations.
  2. severe cyanotic congenital heart disease (such as transposition of great artery, tetralogy of Fallot, etc.) which affects systemic hemodynamics.
  3. congenital hereditary metabolic diseases.
  4. parental informed consent was not obtained.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: LISA+SNIPPV group
receives PS by the way of invasive surfactant administration technique and selects nasal synchronized intermittent positive pressure ventilation
Procedure: LISA+SNIPPV
The LISA+SNIPPV group receives PS by the way of invasive surfactant administration technique and selects nasal synchronized intermittent positive pressure ventilation.
Active Comparator: InSurE group
receives intubation-surfactant- extubation technique and selects CPAP ventilation
Procedure: traditional InSurE
The traditional InSurE group receives intubation-surfactant- extubation technique and selects CPAP ventilation.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
the average duration of mechanical ventilation
Time Frame: 40 weeks
the average duration of mechanical ventilation of each group
40 weeks
the duration of oxygen therapy
Time Frame: 40 weeks
the duration of oxygen therapy of each group
40 weeks
the incidence of BPD
Time Frame: 28 days
the incidence of BPD in each group
28 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pulmonary Severity Score (PSC)
Time Frame: 1st, 2nd, 3rd, 7th, 14th, 28th days
PSC was defined as FiO2 × support + medications, where FiO2 is the actual or 'effective' (for nasal cannula) FiO2; support is 2.5 for a ventilator, 1.5 for nasal continuous positive airway pressure, or 1.0 for nasal cannula or hood oxygen; and medications is 0.20 for systemic steroids for BPD, 0.10 each for regular diuretics or inhaled steroids, and 0.05 each for methylxanthines or intermittent diuretics. The scores can range from 0.21 to 2.95.
1st, 2nd, 3rd, 7th, 14th, 28th days
the incidence of complications
Time Frame: 40 weeks
the incidence of complications (e.g. necrotizing enterocolitis, cholestasis, retinopathy of prematurity, extrauterine growth retardation)
40 weeks
oxygenation index and ventilation function (PaO2、a/APO2、FiO2、PaCO2)
Time Frame: the period of oxygen therapy
oxygenation index and ventilation function (PaO2、a/APO2、FiO2、PaCO2)
the period of oxygen therapy

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The First Affiliated Hospital with Nanjing Medical University

Investigators

  • Study Director: Xiaoqing Chen, Dr, The First Affiliated Hospital with Nanjing Medical University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 1, 2018

Primary Completion (Anticipated)

December 31, 2019

Study Completion (Anticipated)

December 31, 2019

Study Registration Dates

First Submitted

June 17, 2019

First Submitted That Met QC Criteria

June 17, 2019

First Posted (Actual)

June 18, 2019

Study Record Updates

Last Update Posted (Actual)

June 21, 2019

Last Update Submitted That Met QC Criteria

June 19, 2019

Last Verified

June 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MOLISAN

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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