Comparison Three Methods on Endotracheal Aspiration in Preterm Infants

October 9, 2024 updated by: SERAP ÖZDEMİR, Istanbul University - Cerrahpasa (IUC)

Comparison the Effects of Facilitated Tucking, Swaddling and Prone Position Applied During Endotracheal Aspiration on Pain, Comfort and Physiological Parameters in Preterm Infants

Stress and pain control are vital for newborns, especially preterm babies. While painful procedures cause physiological changes in the short term, they negatively affect brain development in the long term. Non-pharmacological interventions with proven efficacy include: fetal position, sucrose, breastfeeding, breast milk, maternal presence, non-nutritive sucking, swaddling (wrapping) and skin-to-skin contact, as well as developmentally supportive positioning. Evaluating the effectiveness of nursing practices to be performed on babies, scientifically proving the most beneficial application that will both alleviate pain and increase their comfort in painful procedures such as aspiration and being more beneficial to babies are among the most basic benefits. Thanks to these applications, it is predicted that your baby will experience less pain and provide more comfort. Therefore, this study aim to comparison the effects of facilitated tucking, swaddling and prone position applied during endotracheal aspiration on pain, comfort and physiological parameters in preterm infants.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The universe of the research; between July-September 2022, patients who are intubated on a mechanical ventilator at 32-36 weeks of gestation (middle preterm group) in Gaziantep Cengiz Gökçek Obstetrics and Pediatrics Hospital Neonatal Intensive Care Unit will consist of. In order to determine the sample size of the study, power analysis was performed using the G*Power (V3.1.9.7) program. According to Cohen's effect size coefficients; Assuming that the effect size (f = 0.4) of the evaluations to be made between four independent groups will be large/large, Taplak and Bayat (2021) found the effect size as 0.932 as a result of the Power analysis based on the PIPP-R results. In this study, it was determined that there should be at least 15 people in all groups (Fetal position, Swaddling, Prone position and control group) according to the new calculation made with 0.932 effect size, 5% alpha (two-sided) and 99% power. Considering that there may be losses during the study, each group will form a sample of 100 infants, 25 infants each. Random assignment of babies to groups will be carried out by the researcher through a computer program (https://www.randomizer.org)/. After determining the groups of premature babies randomly, one group will be given fetal position, one group swaddling position and one group prone position before, during and after endotracheal aspiration. Pain scores (PIPP-R), comfort scores (Comfort Scale) and physiological parameters (Heart peak beat, oxygen saturation value measured by pulse oximetry) 3 minutes before, during and after these nursing practices in the 1st and 3rd minutes after the procedure.

Study Type

Interventional

Enrollment (Actual)

100

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
      • Gaziantep, Turkey, 27310
        • Gaziantep University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

6 months to 8 months (Child)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Having 28-35 weeks of gestation,
  • Follow-up as intubated in SIMV mode on mechanical ventilator,
  • Follow-up on a ventilator between 1-10 days,
  • Having a body weight of ≥1000 g,
  • Those who have not taken any opioid or sedative medication until 4 hours before the procedure will be included.

Exclusion Criteria:

  • Presence of congenital anomaly,
  • Chest tube inserted
  • Intracranial bleeding,
  • Presence of condition/anomaly that will prevent prone tilting,
  • Those with a history of epileptic seizures will be excluded.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Facilitated Tucking
giving facilitated tucking before, during and after the procedure
Other: Facilitated Tucking
giving facilitated tucking before (1st and 3th minutes), during and after (1st and 3th minutes) the procedure
Experimental: Swaddling
giving swaddling before, during and after the procedure
Other: Swaddling
swaddling before (1st and 3th minutes), during and after (1st and 3th minutes) the procedure
Experimental: Prone position
giving prone position before, during and after the procedure
Other: Prone Position
giving prone position before (1st and 3th minutes), during and after (1st and 3th minutes) the procedure
No Intervention: control
Rutin care in the neonatal intensive care unit

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pain scores
Time Frame: 6 minutes
Premature infant pain profile-revised (PIPP-R) (min=0 max=21, the higher the score, the more severe the pain)
6 minutes
Comfort score
Time Frame: 6 minutes
Newborn Comfort Behavior Scale (min=6 max=30, High scores signify that the infant is not comfortable)
6 minutes
physiological parameter (Heart rate)
Time Frame: 6 minutes
6 minutes
physiological parameter (oxygen saturation)
Time Frame: 6 minutes
6 minutes

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Istanbul University - Cerrahpasa (IUC)

Collaborators

Kilis 7 Aralik University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 3, 2024

Primary Completion (Actual)

July 3, 2024

Study Completion (Actual)

September 3, 2024

Study Registration Dates

First Submitted

June 21, 2022

First Submitted That Met QC Criteria

June 27, 2022

First Posted (Actual)

June 28, 2022

Study Record Updates

Last Update Posted (Actual)

October 15, 2024

Last Update Submitted That Met QC Criteria

October 9, 2024

Last Verified

September 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IstanbulS

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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