Comparison Three Methods on Endotracheal Aspiration in Preterm Infants

NCT05434364 | Completed DMC

• 1 other identifier: IstanbulS
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Preterm; Pain, Acute; Physiological Stress; Nursing Care; Comfort

Outcome Measures

Primary Outcomes (4)

• Pain scores

  Premature infant pain profile-revised (PIPP-R) (min=0 max=21, the higher the score, the more severe the pain)

  6 minutes

• Comfort score

  Newborn Comfort Behavior Scale (min=6 max=30, High scores signify that the infant is not comfortable)

  6 minutes

• physiological parameter (Heart rate)

  6 minutes

• physiological parameter (oxygen saturation)

  6 minutes

Study Arms (4)

Facilitated Tucking

EXPERIMENTAL

giving facilitated tucking before, during and after the procedure

Other: Facilitated Tucking

Swaddling

EXPERIMENTAL

giving swaddling before, during and after the procedure

Other: Swaddling

Prone position

EXPERIMENTAL

giving prone position before, during and after the procedure

Other: Prone Position

control

NO INTERVENTION

Rutin care in the neonatal intensive care unit

Interventions

Facilitated Tucking OTHER

giving facilitated tucking before (1st and 3th minutes), during and after (1st and 3th minutes) the procedure

Facilitated Tucking

Swaddling OTHER

swaddling before (1st and 3th minutes), during and after (1st and 3th minutes) the procedure

Swaddling

Prone Position OTHER

giving prone position before (1st and 3th minutes), during and after (1st and 3th minutes) the procedure

Prone position

Eligibility Criteria

• Age: 28 Weeks - 35 Weeks
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Istanbul University - Cerrahpasa: lead
• Kilis 7 Aralik University: collaborator

Study Sites (1)

Gaziantep University

Gaziantep, Gaziantep, 27310, Turkey (Türkiye)

Location

Related Publications (3)

• 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.

  PMID: 31229348 BACKGROUND

• 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.

  PMID: 26002861 BACKGROUND

• 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.

  PMID: 25060423 BACKGROUND

MeSH Terms

Conditions

Premature Birth; Acute Pain

Interventions

Facilitated Tucking; Prone Position

Condition Hierarchy (Ancestors)

Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Infant Care; Child Care; Health Services; Health Care Facilities Workforce and Services; Posture; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Doctor

Study Record Dates

• First Submitted: June 21, 2022
• First Posted: June 28, 2022
• Study Start: February 3, 2024
• Primary Completion: July 3, 2024
• Study Completion: September 3, 2024
• Last Updated: October 15, 2024

Record last verified: 2024-09

Locations

TU (1)