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Comparison Three Methods on Endotracheal Aspiration in Preterm Infants

Primary Purpose

Preterm, Pain, Acute, Physiological Stress

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Facilitated Tucking
Swaddling
Prone Position
Sponsored by
Istanbul University - Cerrahpasa (IUC)
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Preterm

Eligibility Criteria

28 Weeks - 35 Weeks (Child)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm 4

    Arm Type

    Experimental

    Experimental

    Experimental

    No Intervention

    Arm Label

    Facilitated Tucking

    Swaddling

    Prone position

    control

    Arm Description

    giving facilitated tucking before, during and after the procedure

    giving swaddling before, during and after the procedure

    giving prone position before, during and after the procedure

    Rutin care in the neonatal intensive care unit

    Outcomes

    Primary Outcome Measures

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

    Secondary Outcome Measures

    Full Information

    First Posted
    June 21, 2022
    Last Updated
    September 8, 2023
    Sponsor
    Istanbul University - Cerrahpasa (IUC)
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05434364
    Brief Title
    Comparison Three Methods on Endotracheal Aspiration in Preterm Infants
    Official Title
    Comparison the Effects of Facilitated Tucking, Swaddling and Prone Position Applied During Endotracheal Aspiration on Pain, Comfort and Physiological Parameters in Preterm Infants
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    September 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    September 21, 2023 (Anticipated)
    Primary Completion Date
    September 21, 2023 (Anticipated)
    Study Completion Date
    September 21, 2023 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Istanbul University - Cerrahpasa (IUC)

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    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.
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Preterm, Pain, Acute, Physiological Stress, Nursing Care, Comfort

    7. Study Design

    Primary Purpose
    Supportive Care
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantCare Provider
    Allocation
    Randomized
    Enrollment
    100 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Facilitated Tucking
    Arm Type
    Experimental
    Arm Description
    giving facilitated tucking before, during and after the procedure
    Arm Title
    Swaddling
    Arm Type
    Experimental
    Arm Description
    giving swaddling before, during and after the procedure
    Arm Title
    Prone position
    Arm Type
    Experimental
    Arm Description
    giving prone position before, during and after the procedure
    Arm Title
    control
    Arm Type
    No Intervention
    Arm Description
    Rutin care in the neonatal intensive care unit
    Intervention Type
    Other
    Intervention Name(s)
    Facilitated Tucking
    Intervention Description
    giving facilitated tucking before (1st and 3th minutes), during and after (1st and 3th minutes) the procedure
    Intervention Type
    Other
    Intervention Name(s)
    Swaddling
    Intervention Description
    swaddling before (1st and 3th minutes), during and after (1st and 3th minutes) the procedure
    Intervention Type
    Other
    Intervention Name(s)
    Prone Position
    Intervention Description
    giving prone position before (1st and 3th minutes), during and after (1st and 3th minutes) the procedure
    Primary Outcome Measure Information:
    Title
    Pain scores
    Description
    Premature infant pain profile-revised (PIPP-R) (min=0 max=21, the higher the score, the more severe the pain)
    Time Frame
    6 minutes
    Title
    Comfort score
    Description
    Newborn Comfort Behavior Scale (min=6 max=30, High scores signify that the infant is not comfortable)
    Time Frame
    6 minutes
    Title
    physiological parameter (Heart rate)
    Time Frame
    6 minutes
    Title
    physiological parameter (oxygen saturation)
    Time Frame
    6 minutes

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    28 Weeks
    Maximum Age & Unit of Time
    35 Weeks
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    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.
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Serap Ozdemir, PhD
    Phone
    +905375438610
    Email
    serap8685@hotmail.com

    12. IPD Sharing Statement

    Plan to Share IPD
    Undecided
    Citations:
    PubMed Identifier
    31229348
    Citation
    Taplak AS, Bayat M. Psychometric Testing of the Turkish Version of the Premature Infant Pain Profile Revised-PIPP-R. J Pediatr Nurs. 2019 Sep-Oct;48:e49-e55. doi: 10.1016/j.pedn.2019.06.007. Epub 2019 Jun 19.
    Results Reference
    result
    PubMed Identifier
    26002861
    Citation
    Hartley KA, Miller CS, Gephart SM. Facilitated tucking to reduce pain in neonates: evidence for best practice. Adv Neonatal Care. 2015 Jun;15(3):201-8. doi: 10.1097/ANC.0000000000000193.
    Results Reference
    result
    PubMed Identifier
    25060423
    Citation
    Lopez O, Subramanian P, Rahmat N, Theam LC, Chinna K, Rosli R. The effect of facilitated tucking on procedural pain control among premature babies. J Clin Nurs. 2015 Jan;24(1-2):183-91. doi: 10.1111/jocn.12657. Epub 2014 Jul 24.
    Results Reference
    result

    Learn more about this trial

    Comparison Three Methods on Endotracheal Aspiration in Preterm Infants

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