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Premedication for Less Invasive Surfactant Administration

ConditionSurfactant Deficiency Syndrome Neonatal
Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
AgeNot listed
SponsorUniversity of Oulu

About this trial

Early respiratory management of preterm infants immediately after birth should be as gentle as possible. With this so-called developmental approach, unnecessary invasive methods can be avoided or at least postponed. This kind of "soft landing" allows cardiorespiratory transition with fewer adverse outcomes. Less invasive surfactant administration (LISA) is a technique that involves delivery of surfactant to a spontaneously breathing infant through a thin catheter. This technique minimizes the risk for neonatal lung injury caused by positive pressure ventilation. LISA is nowadays widely used in neonatal intensive care units (NICU). Although less invasive, newborns exposed to this procedure need premedication prior the procedure. There is no consensus, which drug would be the optimal premedication for LISA and the research on this topic is lacking. An ideal premedication would treat the procedural pain without suppressing the infant's own breathing. The sedation and analgesia should start fast but the effect should be short-acting with as few adverse effects as possible. The aim of this randomized, controlled trial (RCT) is to evaluate the feasibility, efficacy and safety of LISA protocol with the premedication of either ketamine or fentanyl by investigating whether one or the other is associated with lower rate of adverse events, hence would be preferred choice for premedication protocol.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Gestational age at birth ≥26 weeks

Respiratory insufficiency managed with non-invasive respiratory support (nasal continuous positive airway pressure or high-flow)

Requirement for oxygen to maintain oxygen saturation in the target range and need for surfactant treatment (according to clinician's assessment)

If further doses of surfactant are needed, patient can be re-randomized

Disqualifiers

Severe RDS with high oxygen requirements, severe respiratory acidosis and/or widespread atelectasis radiologically, such that ongoing ventilator support will be necessary after surfactant therapy (intubation in preferable to LISA if FiO2 >40% at GA <28 weeks and >60% at GA ≥28 weeks)

Maxillo-facial, tracheal or known pulmonary malformations

Any known chromosomal abnormality or severe malformation

An alternative cause for respiratory distress (e.g. congenital pneumonia or pulmonary hypoplasia)

Trial design

Design model

Parallel

Treatments tested in this trial

  • Ketamine

    Drug

    Individuals will receive randomly either ketamine or fentanyl as a premedication

  • Fentanyl

    Drug

    Individuals will receive randomly either ketamine or fentanyl as a premedication

Treatment groups

40 Participants
are divided into 2 treatment groups
Group A: KetamineExperimental treatment 1 intervention
Group B: FentanylExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Adverse event

The need of positive pressure ventilation (PPV), intubation, heart rate below 80 per minute, mean arterial pressure change more than 20%, pH change more than 0.4, and CO2 change more than 20%, and saturation \<85 for more than 1 minute

Time frame
1 hour

Secondary outcomes

1

Duration of the procedure

Duration of the procedure is evaluated retrospectively from the recording of the videolaryngoscopy (an attempt begins when the laryngoscope enters the mouth and ends with LISACath in the trachea)

Time frame
1 hour
2

Number of attempts to get the catether intratracheally

Number of attempts to get the catether intratracheally is evaluated retrospectively from the recording of the videolaryngoscopy (one laryngoscopy = one attempt)

Time frame
1 hour
3

Pain score NIAPAS

Pain will be scored with validated Neonatal Infant Acute Pain Assessment Scale (NIAPAS) tool. The scale includes five behavioral and three physiological indicators, and takes into account the gestational age of neonates as a contextual factor. The indicators are rated on a 2, 3, or 4-point scale for a possible total score of 18. Assessments of each neonate include alertness, facial expressions, crying, muscle tension, reaction to handling, and breathing. In addition, the neonates on monitors are assessed for changes in heart rate and oxygen saturation (Copyright Pölkki T, Korhonen A, Axelin A. 2013)

Time frame
1 hour
4

The need for additional dosing of study drug or midazolam (number of addtional dosages)

If the study drug does not have sufficient effect, the study drug may be repeated with the same dose. If study drug fails to give appropriate conditions to LISA procedure, midazolam 0,1 mg/kg can be used as an additional drug.

Time frame
1 hour

Other outcomes

Sponsors and contacts

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University of Oulu

Lead sponsor

Oulu University Hospital

Collaborator

Source ClinicalTrials.gov
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