Less Invasive Surfactant Administration in Late Preterm or Early Term Born Infants
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age34-38
SponsorKing's College Hospital NHS Trust
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Infants born at 34+0 to 38+6 weeks of gestation, requiring resuscitation at birth, but who achieve regular spontaneous breathing and have a heart rate over 100 beats per minute while receiving non-invasive support.
Infants enrolled in the Surfon trial, born at 34+0 to 38+6 weeks of gestation, who are less than or equal to 24 hours old and exhibit signs of respiratory distress, defined as an FiO2 greater or equal to 0.30 but less than 0.45 needed to maintain an SpO2 greater than or equal to 92% or a clinically significant work of breathing regardless of the FiO2 and a clinical decision to provide non-invasive respiratory support.
Disqualifiers
Infants requiring intubation at birth
Infants with severe congenital anomalies.
Trial design
Design model
Parallel
Treatments tested in this trial
Less invasive surfactant administration during high flow nasal cannula treatment
Procedure/SurgerySurfactant distilled through a small tube inserted into the windpipe via the mouth whilst the baby is awake and supported with HFNC.
Treatment groups
245 Participants
are divided into 2 treatment groupsGroup A: Neonates given LISA during HFNC treatmentExperimental treatment 1 intervention
Group B: Neonates not given LISANo intervention 0 interventions
Trial outcomes
Primary outcomes
1
The percentage of neonates needing invasive ventilation within 72 hours from birth
The percentage of babies requiring more respiratory support and therefore needing invasive ventilation within 72 hrs from birth. The percentage from the intervention group will be compared with the control group
Time frame
72 hours from birthSecondary outcomes
1
The length of neonatal unit stay
The duration of stay on the neonatal unit will be compared between the babies receiving the intervention, and those who are not.
Time frame
The length of time the neonate is in hospital, up to 20 weeks2
The cost of stay as estimated via standard NHS tariffs according to level of care
Standard NHS tariffs will be used to calculate the total cost of the stay for the babies in the intervention vs control group.
Time frame
The length of time the neonate is in hospital, up to 20 weeks3
The lung function parameters two minutes before and two minutes after the administration of LISA
The following lung function parameter: tidal volume will be measured for all babies receiving LISA.
Time frame
The first 24 hours of life4
The lung function parameters two minutes before and two minutes after the administration of LISA
The following lung function parameter: respiratory rate will be measured for all babies receiving LISA.
Time frame
The first 24 hours of lifeSponsors and contacts
Click on the lead sponsor to view all of their trials.
King's College Hospital NHS Trust
Lead sponsor
Chiesi Limited
Collaborator
Source ClinicalTrials.gov