Premedication for Less Invasive Surfactant Administration

NCT03735563 | Recruiting Phase 4

• 1 other identifier: OY062018
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Surfactant Deficiency Syndrome Neonatal

Keywords

less invasive surfactant administration; premedication

Outcome Measures

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

  1 hour

Secondary Outcomes (5)

• Duration of the procedure

  1 hour

• Number of attempts to get the catether intratracheally

  1 hour

• Pain score NIAPAS

  1 hour

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

  1 hour

• Edi-signals

  1 hour

Study Arms (2)

Ketamine

EXPERIMENTAL

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.

Drug: Ketamine

Fentanyl

EXPERIMENTAL

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.

Drug: Fentanyl

Interventions

Ketamine DRUG

Individuals will receive randomly either ketamine or fentanyl as a premedication

Also known as: Ketanest-S

Ketamine

Fentanyl DRUG

Individuals will receive randomly either ketamine or fentanyl as a premedication

Also known as: Fentanyl-Hamel

Fentanyl

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• University of Oulu: lead
• Oulu University Hospital: collaborator

Study Sites (1)

Oulu University Hospital

Oulu, Finland

RECRUITING

Related Publications (3)

• Sweet DG, Carnielli V, Greisen G, Hallman M, Ozek E, Plavka R, Saugstad OD, Simeoni U, Speer CP, Vento M, Visser GH, Halliday HL. European Consensus Guidelines on the Management of Respiratory Distress Syndrome - 2016 Update. Neonatology. 2017;111(2):107-125. doi: 10.1159/000448985. Epub 2016 Sep 21.

  PMID: 27649091 BACKGROUND

• Vento M, Dargaville P, Bohlin K, Herting E & Roehr C LISA Training Advisory Board Report.

  BACKGROUND

• Polkki T, Korhonen A, Axelin A, Saarela T, Laukkala H. Development and preliminary validation of the Neonatal Infant Acute Pain Assessment Scale (NIAPAS). Int J Nurs Stud. 2014 Dec;51(12):1585-94. doi: 10.1016/j.ijnurstu.2014.04.001. Epub 2014 Apr 18.

  PMID: 24815773 BACKGROUND

MeSH Terms

Conditions

Pulmonary Atelectasis

Interventions

Ketamine; Fentanyl

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Riitta Marttila, MD, docent

  Oulu University and Oulu University Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Eveliina Ronkainen, MD, PhD

CONTACT

+358 8 3152011; eveliina.ronkainen@oulu.fi

Antti Härmä, MD

CONTACT

+358 8 3152011; aharma@paju.oulu.fi

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: The 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 7, 2018
• First Posted: November 8, 2018
• Study Start: February 11, 2019
• Primary Completion: October 31, 2025
• Study Completion (Estimated): October 31, 2026
• Last Updated: June 5, 2023

Record last verified: 2023-06

Data Sharing

• IPD Sharing: Will not share

Locations

FI (1)