Ignite Creation Date:
2025-12-26 @ 5:19 PM
Ignite Modification Date:
2025-12-29 @ 5:23 AM
Study NCT ID:
NCT06421506
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-05-22
First Post:
2024-05-09
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Less Invasive Surfactant Administration in Late Preterm or Early Term Born Infants
Sponsor:
King's College Hospital NHS Trust
Organization:
Study Overview
Official Title:
Does Less Invasive Surfactant Administration (LISA) During High-flow Nasal Cannula Oxygen Treatment Reduces the Need for Invasive Ventilation in Late Preterm and Term Born Infants With Respiratory Distress?
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The aim of this study is to see if giving less invasive surfactant administration (LISA) during high-flow nasal cannula (HFNC) oxygen treatment reduces the need for invasive ventilation in babies with breathing problems born 2-6 weeks early.
Less invasive surfactant administration is where surfactant (a naturally produced substance which helps open up the tiny air sacs in the lungs making it easier for babies to breathe) is given into the lungs by putting a small tube into the windpipe through the mouth whilst the baby is awake. The surfactant is given slowly and breathed in.
High flow nasal cannula is a form of non-invasive support where a machine delivers warmed, moist oxygen and air through short tubes in the nose.
The investigators will be assessing whether a lower percentage of neonates need invasive ventilation within 72 hrs from birth when they have had LISA during HFNC treatment, compared to when they don't receive this treatment.
The investigators will also be looking at the length of neonatal unit stay and the cost of the stay. The investigators will also be measuring the lung function of the babies before and after they receive LISA.
Less invasive surfactant administration is where surfactant (a naturally produced substance which helps open up the tiny air sacs in the lungs making it easier for babies to breathe) is given into the lungs by putting a small tube into the windpipe through the mouth whilst the baby is awake. The surfactant is given slowly and breathed in.
High flow nasal cannula is a form of non-invasive support where a machine delivers warmed, moist oxygen and air through short tubes in the nose.
The investigators will be assessing whether a lower percentage of neonates need invasive ventilation within 72 hrs from birth when they have had LISA during HFNC treatment, compared to when they don't receive this treatment.
The investigators will also be looking at the length of neonatal unit stay and the cost of the stay. The investigators will also be measuring the lung function of the babies before and after they receive LISA.
Detailed Description:
This study is looking at babies born 2- 6 weeks early who have breathing problems soon after birth. Some babies need to go onto a breathing machine (ventilator) or require 'non-invasive' breathing support. Either a machine delivers warmed, moist oxygen + air through short tubes in the nose (humidified high flow nasal cannula, HHFNC) or a machine delivers oxygen and air via a small mask which fits over the nose (continuous positive airway pressure, CPAP). Mechanical ventilation via a ventilator, although life-saving, can cause problems such as infection and lung injury and, therefore, whenever possible baby's breathing is supported with 'non-invasive' methods. The use of CPAP in more mature babies may also cause discomfort or lung collapse, whereas use of HHFNC may avoid those problems. The lungs of healthy full-term babies naturally produce a substance called surfactant that helps open up the tiny air sacs in the lungs and makes it easier for them to breathe. Babies born early or those with problems at birth, do not have enough of their own surfactant or it does not work properly, causing difficulty in taking in oxygen. A natural, animal-derived surfactant medication can be given into the lungs, using a small tube put into the windpipe through the mouth. This is done routinely in ventilated babies born prematurely. More recently, a technique called 'Less invasive surfactant administration (LISA)' has been developed that allows us to give surfactant to babies who are receiving 'non-invasive' breathing support (ie HHFNC) and, thus, avoiding the complications related to mechanical ventilation. A small tube is passed into the windpipe whilst the baby is awake and breathing (supported on HHFNC or CPAP) and the surfactant is slowly given and breathed into the lungs. At the moment, there have been no research studies assessing the use of LISA in more mature infants receiving HHFNC as 'non-invasive' respiratory support.
In this study the investigators want to determine if in babies born between 34 and 38+6 weeks gestation who have breathing problems and receive HHFNC oxygen treatment with LISA within 24 hours of birth will reduce the need for mechanical ventilation. The investigators will also be looking a the length on neonatal unit stay, and the cost of the stay. Lung function of the babies before and after they receive LISA will be measured.
There will be no change in the management of babies taking part in the study. Use of HHFNC, administration of LISA and respiratory monitoring is all part of routine practice. The investigators are asking for consent to analyse the routine monitoring that will be undertaken before, during and after the surfactant administration and follow up on the outcome of the baby after they have had the LISA procedure.
Surfactant is routinely used in babies and there are no extra risks from taking part in this study. HHFNC is routinely used to support babies of this gestational age who require respiratory support. There are no known or expected risks from using HHFNC with LISA but as of yet there have been no studies using this combination.
Giving surfactant may help to avoid mechanical ventilation and its side effects, but this has not been studied before in these gestational ages, hence the need for this study. Theoretically giving surfactant with HHFNC should aid even distribution of surfactant throughout the lungs whilst protecting the lungs from potential damage caused by other forms of non-invasive support such as CPAP but again there is not yet evidence supporting this.
The study will be running at King's College Hospital on the Neonatal Intensive Care Unit at the Denmark hill site and at the Local Neonatal Unit at the Princess Royal Hospital site. The study has received ethical approval and is due to commence imminently (May 2024). The study is aiming to recruit 245 patients which is estimated to take 2yrs and 4 months.
The study is funded by Chiesi Limited. The chief investigator for the study is Theodore Dassios: theodore.dassios@kcl.ac.uk
In this study the investigators want to determine if in babies born between 34 and 38+6 weeks gestation who have breathing problems and receive HHFNC oxygen treatment with LISA within 24 hours of birth will reduce the need for mechanical ventilation. The investigators will also be looking a the length on neonatal unit stay, and the cost of the stay. Lung function of the babies before and after they receive LISA will be measured.
There will be no change in the management of babies taking part in the study. Use of HHFNC, administration of LISA and respiratory monitoring is all part of routine practice. The investigators are asking for consent to analyse the routine monitoring that will be undertaken before, during and after the surfactant administration and follow up on the outcome of the baby after they have had the LISA procedure.
Surfactant is routinely used in babies and there are no extra risks from taking part in this study. HHFNC is routinely used to support babies of this gestational age who require respiratory support. There are no known or expected risks from using HHFNC with LISA but as of yet there have been no studies using this combination.
Giving surfactant may help to avoid mechanical ventilation and its side effects, but this has not been studied before in these gestational ages, hence the need for this study. Theoretically giving surfactant with HHFNC should aid even distribution of surfactant throughout the lungs whilst protecting the lungs from potential damage caused by other forms of non-invasive support such as CPAP but again there is not yet evidence supporting this.
The study will be running at King's College Hospital on the Neonatal Intensive Care Unit at the Denmark hill site and at the Local Neonatal Unit at the Princess Royal Hospital site. The study has received ethical approval and is due to commence imminently (May 2024). The study is aiming to recruit 245 patients which is estimated to take 2yrs and 4 months.
The study is funded by Chiesi Limited. The chief investigator for the study is Theodore Dassios: theodore.dassios@kcl.ac.uk
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: