The primary objective of this study is to compare the level of stress and comfort of preterm infants when sedation is given during the MIST procedure compared to no sedation.
ID
Source
Brief title
Condition
- Respiratory disorders congenital
- Neonatal and perinatal conditions
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The main study parameter is the comfort-neo score, the primary endpoint is the
percentage of infants with a comfort-neo score below 14 during the procedure.
Secondary outcome
Secondary study parameters are;
- Occurrence of positive pressure ventilation during and right after the
procedure;
- Occurrence of intubation needed during the procedure and within 24 hours;
- Number of attempts of endotracheal insertion of angiocatheter;
- Duration of the total procedure (from start inserting laryngoscope, until
exit angiocatheter);
- Complications occurring during the procedure: desaturation < 85%, hypotension
(mean below gestational age), bradycardia < 80 bpm, nasal hemorrhage;
- Other complications: pneumothorax, pulmonary haemorrhage, resuscitation;
- Heart rate and blood pressure before, during and 5 minutes after the
procedure.
Background summary
Premature infants who are at risk of developing Respiratory Distress Syndrome
(RDS) require surfactant therapy to reduce the risk op pneumothorax and
neonatal death. In the traditional method, surfactant is instilled after
endotracheal intubation and when the infant is mechanically ventilated, but
minimally invasive surfactant therapy (MIST) is promising, in which surfactant
is administered via an endotracheal catheter to a spontaneously breathing
infant who then remains on non invasive ventilation (CPAP). In this way,
possible disadvantageous effects of intubation and mechanical ventilation can
be avoided. Although infants are routinely sedated for endotracheal intubation,
it is unclear whether during a MIST procedure sedation should be given.
Study objective
The primary objective of this study is to compare the level of stress and
comfort of preterm infants when sedation is given during the MIST procedure
compared to no sedation.
Study design
A single blind randomized trial.
Intervention
The administration of propofol (1 mg/kg) versus no sedation. In both groups
standard comfort care will be given, which consists of administering sucrose
24% in the cheek pouch of the infant together with containing the infant with
his pacifier two minutes before the intervention starts, and containing the
infant during the procedure.
Study burden and risks
When randomized to the use of sedation, both risk and benefit are possible.
Propofol is the standard sedative used in the unit, there is a low risk for
side effects such as apnea, bradycardia and hypotension. The risk is minimal as
we will be using a lower dose then standardly used for endotracheal intubation
(1 mg/kg instead of 2.5 mg/kg). Also, all standard precautions will be taken
for immediate counteract/treatment of the possible side effects of propofol.
The possible benefits in the sedation group are more comfort during the
procedure and a higher chance to a successful procedure at the first attempt.
Albinusdreef 2
Leiden 2333 ZA
NL
Albinusdreef 2
Leiden 2333 ZA
NL
Listed location countries
Age
Inclusion criteria
Preterm infants (26-37 weeks of gestation) needing surfactant therapy for RDS according to local criteria (FiO2 > 30% and PEEP > 8).
Exclusion criteria
Imminent need for intubation because of respiratory distress, apnea or persistent acidosis.
Infants who suffer from pneumothorax or pulmonary hemorrhage.
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL50864.058.14 |