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
Premedication for Less Invasive Surfactant Administration
Brief Summary
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.
Intervention / Treatment
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Ketamine (DRUG)Individuals will receive randomly either ketamine or fentanyl as a premedication
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Fentanyl (DRUG)Individuals will receive randomly either ketamine or fentanyl as a premedication
Condition or Disease
- Surfactant Deficiency Syndrome Neonatal
Phase
Study Design
| Study type: | INTERVENTIONAL |
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| Status: | Recruiting |
| Study results: | No Results Available |
| Age: | Child, Adult, Older Adult |
| Enrollment: | 40 (ESTIMATED) |
| Funded by: | Other |
| Allocation: | Randomized |
| Primary Purpose: | Treatment |
MaskingThe investigators and medical staff are blinded to the fact which study medication is given. A pharmacist or a nurse not participating in treatment of the child in question prepares the drug. Preparation of the study drug is done in a different location than where the treatment takes place. QUADRUPLE:
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Clinical Trial Dates
| Start date: | Feb 11, 2019 | ACTUAL |
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| Primary Completion: | Oct 31, 2025 | ESTIMATED |
| Completion Date: | Oct 31, 2026 | ESTIMATED |
| Study First Posted: | Nov 08, 2018 | ACTUAL |
| Results First Posted: | Aug 31, 2020 | |
| Last Updated: | Jun 02, 2023 |
Sponsors / Collaborators
Location
All infants fulfilling the inclusion criteria during the study period are asked to participate in this randomized controlled trial of LISA premedication. Written informed parental consent is acquired from all of the participants. After the consent, individuals needing the LISA will receive premedication as follows: caffeine (in case of gestational age \<32 weeks and not already given), glycopyrrolate, and randomly either ketamine or fentanyl. The investigators and medical staff are blinded to the fact which study medication is given. This study is a pilot study and 20 patients are recruited for both groups. Randomization is done in the blocks of four.
S-ketamine (Ketanest-S 5 mg/ml) or fentanyl (Fentanyl-Hamel diluted to 5 μg/ml) is used as a masked study drug. Both study drug solutions appear equally transparent. Drug administration is started with glucopyrrolate (Robinul 0.2 mg/ml), which is given intravenously at a dose of 5 µg/kg. Thereafter, the masked study drug is administered intravenously slowly in one to two minute injection of 0.2 ml/kg. In this way, doses of S-ketamine 1 mg/kg or alternatively fentanyl 1 μg/kg is received. After five minutes (from the beginning of administration of the study drug), videolaryngoscopy is started. 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.
S-ketamine (Ketanest-S 5 mg/ml) or fentanyl (Fentanyl-Hamel diluted to 5 μg/ml) is used as a masked study drug. Both study drug solutions appear equally transparent. Drug administration is started with glucopyrrolate (Robinul 0.2 mg/ml), which is given intravenously at a dose of 5 µg/kg. Thereafter, the masked study drug is administered intravenously slowly in one to two minute injection of 0.2 ml/kg. In this way, doses of S-ketamine 1 mg/kg or alternatively fentanyl 1 μg/kg is received. After five minutes (from the beginning of administration of the study drug), videolaryngoscopy is started. 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.
Participant Groups
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Individuals needing the LISA will receive premedication as follows: caffeine (in case of gestational age \<32 weeks and not already given), glycopyrrolate, and randomly either ketamine or fentanyl.
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Individuals needing the LISA will receive premedication as follows: caffeine (in case of gestational age \<32 weeks and not already given), glycopyrrolate, and randomly either ketamine or fentanyl.
Eligibility Criteria
| Sex: | All |
|---|---|
| Age Groups: | Child / Adult / Older Adult |
| Healthy Volunteers: | Yes |
Inclusion Criteria:
* 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
Exclusion Criteria:
* 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)
* 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
Exclusion Criteria:
* 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)
This clinical trial is recruiting
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Primary Outcomes
Secondary Outcomes
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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)
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Number of attempts to get the catether intratracheally is evaluated retrospectively from the recording of the videolaryngoscopy (one laryngoscopy = one attempt)
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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)
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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.
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Special Edi (Electronic Diaphragm Monitoring) Catheter is placed to read the electrical activity of the diaphragm. Edi min and Edi max in different time points will be collected.
More Details
| NCT Number: | NCT03735563 |
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| Acronym: | LISA-Med |
| Other IDs: | OY062018 |
| Study URL: | https://clinicaltrials.gov/study/NCT03735563 |
Last updated: Sep 29, 2023