Preterm InfantsPhase 2NCT04126382
LISA vs INSURE in the Treatment of Respiratory Distress Syndrome in Preterm Infants
A Phase 2 study testing Intubate-Surfactant-Extubate(INSURE) and less invasive surfactant administration(LISA) in people with Preterm Infants, run by Anhui Provincial Hospital.
Trial 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. Read more about this study
- Who is it for?
- Ages 25 to 32 weeks
- Conditions the study is for
- Preterm Infants
- What is being tested?
- Intubate-Surfactant-Extubate(INSURE) and less invasive surfactant administration(LISA)
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2020to 31 Dec 2024
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 25 to 32 weeks
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
No sites are listed yet.
About this study
Official title: The Efficacy of LISA Technology With Noninvasive Ventilation in the Treatment of Respiratory Distress Syndrome in Preterm Neonates
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.
Read the 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.
- Conditions
- Preterm Infants
- Being tested
- Intubate-Surfactant-Extubate(INSURE), less invasive surfactant administration(LISA)
- Keywords
- NRDS, preterm infants, LISA, INSURE
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intubate-Surfactant-Extubate(INSURE)Procedure or surgery
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.
less invasive surfactant administration(LISA)Procedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| INSURE | Active comparator | Intubate-Surfactant-Extubate(INSURE) technique is a Important treatment in premature infants with RDS. Receives: Procedure: Intubate-Surfactant-Extubate(INSURE) |
| LISA | Experimental | Less invasive surfactant administration(LISA) technique is a Important treatment in premature infants with RDS. Receives: Procedure: less invasive surfactant administration(LISA) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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.
Measured: at a post-menstrual age of 36 weeks or at discharge
Secondary outcomes (12)
Effect on of arterial blood gas analysis
The improvement of PaO2 and PaCO2 in two groups children with LISA technique
Measured: during the whole procedure of surfactant replacement,up to 3 days after birth
The Incidence of Patent ductus arteriosus
PDA was diagnosed based on echocardiography
Measured: during hospitalization, up to 60 days
The Incidence of Pneumothorax
Pneumothorax was diagnosed based on clinical manifestations and features of chest x-ray
Measured: during non-invasive ventilation, up to 30 days
The Incidence of Abdominal Distention
Abdominal circumference was measured 3 times a day during non-invasive ventilation
Measured: during non-invasive ventilation, up to 30 days
The Incidence of Neonatal Necrotizing Enterocolitis(>Stage II)
Neonatal Necrotizing Enterocolitis was diagnosed by clinical manifestations and features of abdominal x-Ray based on the Practical neonatology 4th edition
Measured: during hospitalization, up to 60 days
The Incidence of Retinopathy of Prematurity( ≥ Stage II)
The criteria for Retinopathy of prematurity (>Stage II); extraretinal fibrovascular proliferation neovascularization extends from ridge into the vitreous.
Measured: at a post-menstrual age of 36 weeks or at discharge
The Incidence of Intraventricular Hemorrhage (IVH, ≥ Grade Ⅲ)
The criteria for intraventricular hemorrhage (IVH, ≥ grade Ⅲ): intraventricular hemorrhage with ventricular dilatation and intraventricular hemorrhage with paren-ehymal hemorrhage.
Measured: during hospitalization, up to 60 days
The Incidence of Periventricular Leukomalacia
Periventricular Leukomalacia was diagnosed based on cranial MRI
Measured: during hospitalization, up to 36 months
Predischarge Mortality
Measured: during hospitalization, up to 60 days
The Time of Non-invasive Ventilation
Hours
Measured: during hospitalization, up to 60 days
Days on supplemental oxygen
Days
Measured: during hospitalization, up to 60 days
Length of Hospitalization
Days
Measured: during hospitalization, up to 60 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Oct 2019
- Study start1 Jan 2020 (estimated)
- Primary completion31 Dec 2024 (estimated)
- Study completion31 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Preterm InfantsStudies of the same condition, open and under way.
- More trials run by Anhui Provincial HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Anhui Provincial Hospital
- Sponsor type
- Other government
- Collaborators
- The First Affiliated Hospital of University of Science and Technology of China, The First Affiliated Hospital of Bengbu Medical University, Second Affiliated Hospital of Bengbu Medical College, 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, First Affiliated Hospital of Wannan Medical College, Tongling People's Hospital, Maanshan maternity and child care, Wuhu first people's hospital, Anqing Municipal Hospital
- Responsible party
- Sponsor
- Investigators
- Pan jiahua, PhD, Study director, Director of pediatric department of the First Affiliated Hospital of University of Science and Technology of China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04126382
- Sponsor's protocol ID
- LISA2020
- Status last verified
- Oct 2019
- First submitted
- 4 Oct 2019
- Last updated
- 15 Oct 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 15 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Efficacy of LISA Technology With Noninvasive Ventilation in the Treatment of Respiratory Distress Syndrome in Preterm Neonates
- ClinicalTrials.gov ID
- NCT04126382
- Acronym / sponsor ID
- LISA2020
- Conditions
- Preterm Infants
- Keywords
- NRDS, preterm infants, LISA, INSURE
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Anhui Provincial HospitalOther government
- Collaborators
- The First Affiliated Hospital of University of Science and Technology of China, The First Affiliated Hospital of Bengbu Medical University, Second Affiliated Hospital of Bengbu Medical College, 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, First Affiliated Hospital of Wannan Medical College, Tongling People's Hospital, Maanshan maternity and child care, Wuhu first people's hospital, Anqing Municipal Hospital
- Study start
- 1 Jan 2020 (estimated)
- Primary completion
- 31 Dec 2024 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 15 Oct 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| INSURE | Active comparator | Procedure: Intubate-Surfactant-Extubate(INSURE)Intubate-Surfactant-Extubate(INSURE) technique is a Important treatment in premature infants with RDS. |
| LISA | Experimental | Procedure: less invasive surfactant administration(LISA)Less invasive surfactant administration(LISA) technique is a Important treatment in premature infants with RDS. |
Who may qualify
- Ages
- 25 to 32 weeks
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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 or surgery | INSURE |
| 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. | Procedure or surgery | LISA |
Primary outcome
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).
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.
12 secondary outcomes
Effect on of arterial blood gas analysis
Time frame: during the whole procedure of surfactant replacement,up to 3 days after birth
The Incidence of Patent ductus arteriosus
Time frame: during hospitalization, up to 60 days
The Incidence of Pneumothorax
Time frame: during non-invasive ventilation, up to 30 days
The Incidence of Abdominal Distention
Time frame: during non-invasive ventilation, up to 30 days
The Incidence of Neonatal Necrotizing Enterocolitis(>Stage II)
Time frame: during hospitalization, up to 60 days
The Incidence of Retinopathy of Prematurity( ≥ Stage II)
Time frame: at a post-menstrual age of 36 weeks or at discharge
The Incidence of Intraventricular Hemorrhage (IVH, ≥ Grade Ⅲ)
Time frame: during hospitalization, up to 60 days
The Incidence of Periventricular Leukomalacia
Time frame: during hospitalization, up to 36 months
Predischarge Mortality
Time frame: during hospitalization, up to 60 days
The Time of Non-invasive Ventilation
Time frame: during hospitalization, up to 60 days
Days on supplemental oxygen
Time frame: during hospitalization, up to 60 days
Length of Hospitalization
Time frame: during hospitalization, up to 60 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Oct 2019.
- Individual participant dataSharing planned: Undecided
Related trials for Preterm Infants
Not yet recruiting
nCPAP-NAVA-Backup Versus Standard nCPAP for Severe Apnea in Preterm Infants ≤28 Weeks
Apnea of Prematurity
Recruiting
Study of the Influence of Intraperitoneal Insufflation of CO2 by Laparoscopy on the Short-term Evolution of Premature Infants With Ulcerative Necrotizing Enterocolitis
Preterm Birth, Enterocolitis, Necrotizing
Recruiting
Comparing Surfactant Administration Through Supraglottic Airway and Thin Catheter for Preterm Infants
Surfactant, Respiratory Distress Syndrome (Neonatal)
Recruiting
Optimization of Saturation Targets And Resuscitation Trial (OptiSTART)
Premature Infants, Bronchopulmonary Dysplasia
RecruitingObservational study
Growing Little PEAPODS Study
Premature Birth, Premature Infant
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Pan jiahua, PhD study director
Director of pediatric department of the First Affiliated Hospital of University of Science and Technology of China
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Intubate-Surfactant-Extubate(INSURE) and less invasive surfactant administration(LISA) in people with Preterm Infants, run by Anhui Provincial Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 15 Oct 2019. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Zhang Lan, PhD (18256935186, moaana@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of intubation (time frame: during the first 3 days after birth). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Oct 2019.