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

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ClinicalTrials.gov Identifier: NCT04126382
Recruitment Status : Not yet recruiting
First Posted : October 15, 2019
Last Update Posted : October 15, 2019
Sponsor:
Collaborators:
the First Affiliated Hospital of University of Science and Technology of China
First Affiliated Hospital Bengbu Medical College
Bengbu medical college second affiliated hospital
Fuyang people's hospital
lixin people's hospital
The third people's hospital of bengbu
Huaibei coal general hospital
Bozhou people's hospital
Luan people's hospital
Huaibei maternal and child health hospital
Huainan maternal and child health hospital
Chizhou people's hospital
Xuancheng people's hospital
The affiliated hospital of wannan medical college
Tongling People's Hospital
Maanshan maternity and child care
Wuhu first people's hospital
Anqing Municipal Hospital
Information provided by (Responsible Party):
Anhui Provincial Hospital

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.

Condition or disease Intervention/treatment Phase
Preterm Infants Procedure: Intubate-Surfactant-Extubate(INSURE) Procedure: less invasive surfactant administration(LISA) Phase 2

Detailed Description:

Background: Neonatal Respiratory distress syndrome (NRDS) is the most common cause of respiratory problems in premature babies. Surfactant administration involved with endotracheal intubation and mechanical ventilation has proven to be a effective treatment, however, it is associated with a risk of barotrauma, volutrauma and bronchopulmonary dysplasia(BPD). In recent years, some studies have demonstrated that prophylactic INSURE did not lead to a higher survival without BPD, and LISA technique is recommended. However there is no multicenter and Large sample research about it. The aim of this multicenter trial is to compare the efficacy between LISA-treated and INSURE-treated premature Preterm babies with respiratory distress syndrome(RDS).

Methods/Design:In this multicenter, randomized, cohort, prospective trial, 200 preterm infants from 18 neonatal intensive care units in AnHui province whose gestational age (GA) less than 32 weeks with a diagnosis of RDS will be randomized to LISA-treated group and INSURE-treated group.

The primary outcomes include rate of intubation,incidence of bronchopulmonary dysplasia(BPD).The secondary outcomes include arterial blood gas analysis,severity of RDS,the incidence of Patent ductus arteriosus(PDA),Pneumothorax,Abdominal Distention,Neonatal Necrotizing Enterocolitis(NEC,>Stage II), Retinopathy of Prematurity( ROP,≥ Stage II), Intraventricular Hemorrhage (IVH, ≥ Grade Ⅲ), Periventricular Leukomalacia(PVL) , mortality, days on noninvasive respiratory support,days on supplemental oxygen and days of hospitalization.Other secondary outcomes include scores of Gesell development Scales of infant development at 3 years of corrected age.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: The Efficacy of LISA Technology With Noninvasive Ventilation in the Treatment of Respiratory Distress Syndrome in Preterm Neonates
Estimated Study Start Date : January 1, 2020
Estimated Primary Completion Date : December 31, 2024
Estimated Study Completion Date : December 31, 2024


Arm Intervention/treatment
Active Comparator: INSURE
Intubate-Surfactant-Extubate(INSURE) technique is a Important treatment in premature infants with RDS.
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.

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




Primary Outcome Measures :
  1. Rate of intubation [ Time Frame: during the first 3 days after birth ]
    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).

  2. The incidence of bronchopulmonary dysplasia [ Time Frame: at a post-menstrual age of 36 weeks or at discharge ]
    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.


Secondary Outcome Measures :
  1. Effect on of arterial blood gas analysis [ Time Frame: during the whole procedure of surfactant replacement,up to 3 days after birth ]
    The improvement of PaO2 and PaCO2 in two groups children with LISA technique

  2. The Incidence of Patent ductus arteriosus [ Time Frame: during hospitalization, up to 60 days ]
    PDA was diagnosed based on echocardiography

  3. The Incidence of Pneumothorax [ Time Frame: during non-invasive ventilation, up to 30 days ]
    Pneumothorax was diagnosed based on clinical manifestations and features of chest x-ray

  4. The Incidence of Abdominal Distention [ Time Frame: during non-invasive ventilation, up to 30 days ]
    Abdominal circumference was measured 3 times a day during non-invasive ventilation

  5. The Incidence of Neonatal Necrotizing Enterocolitis(>Stage II) [ Time Frame: during hospitalization, up to 60 days ]
    Neonatal Necrotizing Enterocolitis was diagnosed by clinical manifestations and features of abdominal x-Ray based on the Practical neonatology 4th edition

  6. The Incidence of Retinopathy of Prematurity( ≥ Stage II) [ Time Frame: at a post-menstrual age of 36 weeks or at discharge ]
    The criteria for Retinopathy of prematurity (>Stage II); extraretinal fibrovascular proliferation neovascularization extends from ridge into the vitreous.

  7. The Incidence of Intraventricular Hemorrhage (IVH, ≥ Grade Ⅲ) [ Time Frame: during hospitalization, up to 60 days ]
    The criteria for intraventricular hemorrhage (IVH, ≥ grade Ⅲ): intraventricular hemorrhage with ventricular dilatation and intraventricular hemorrhage with paren-ehymal hemorrhage.

  8. The Incidence of Periventricular Leukomalacia [ Time Frame: during hospitalization, up to 36 months ]
    Periventricular Leukomalacia was diagnosed based on cranial MRI

  9. Predischarge Mortality [ Time Frame: during hospitalization, up to 60 days ]
  10. The Time of Non-invasive Ventilation [ Time Frame: during hospitalization, up to 60 days ]
    Hours

  11. Days on supplemental oxygen [ Time Frame: during hospitalization, up to 60 days ]
    Days

  12. Length of Hospitalization [ Time Frame: during hospitalization, up to 60 days ]
    Days



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Ages Eligible for Study:   25 Weeks to 32 Weeks   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04126382


Contacts
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Contact: Zhang Lan, PhD 18256935186 moaana@163.com
Contact: Pan Jiahua, PhD 13866167758 panjiahua1960@163.com

Sponsors and Collaborators
Anhui Provincial Hospital
the First Affiliated Hospital of University of Science and Technology of China
First Affiliated Hospital Bengbu Medical College
Bengbu medical college second affiliated hospital
Fuyang people's hospital
lixin people's hospital
The third people's hospital of bengbu
Huaibei coal general hospital
Bozhou people's hospital
Luan people's hospital
Huaibei maternal and child health hospital
Huainan maternal and child health hospital
Chizhou people's hospital
Xuancheng people's hospital
The affiliated hospital of wannan medical college
Tongling People's Hospital
Maanshan maternity and child care
Wuhu first people's hospital
Anqing Municipal Hospital
Investigators
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Study Director: Pan jiahua, PhD Director of pediatric department of the First Affiliated Hospital of University of Science and Technology of China

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Responsible Party: Anhui Provincial Hospital
ClinicalTrials.gov Identifier: NCT04126382    
Other Study ID Numbers: LISA2020
First Posted: October 15, 2019    Key Record Dates
Last Update Posted: October 15, 2019
Last Verified: October 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Anhui Provincial Hospital:
NRDS
preterm infants
LISA
INSURE
Additional relevant MeSH terms:
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Respiratory Distress Syndrome, Newborn
Respiratory Distress Syndrome, Adult
Premature Birth
Obstetric Labor, Premature
Obstetric Labor Complications
Pregnancy Complications
Lung Diseases
Respiratory Tract Diseases
Respiration Disorders
Infant, Premature, Diseases
Infant, Newborn, Diseases
Pulmonary Surfactants
Respiratory System Agents