Effect of Implementing Evidence Based Practices on Prevention of Associated Nasal Pressure Injuries Among Preterm Neonates With Non-Invasive Respiratory Support

NCT06642285 | Recruiting

• 1 other identifier: KafrelsheikhU4
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

This study aims to evaluate the effect of implementing evidence based practices on prevention of associated nasal pressure injuries among preterm neonates with non invasive respiratory support

Conditions

Mechanical Ventilation Complication; Respiratory Distress Syndrome in Premature Infant

Outcome Measures

Primary Outcomes (2)

• change from the baseline nasal skin integrity on Nasal injury classification tool

  : it is adopted from (Fischer et al., 2010) based on the standardized classification of the decubitus lesions from the US National Pressure Ulcer Advisory Panel (NPUAP) (Black et al., 2007; The National Pressure Ulcer Advisory Panel, 1989). This tool will be employed to describe and track the progression and severity of nasal injuries caused by NIRS in neonates by assessing nasal region (the nasal tip, nasal septum, nostril, and nose shape change) for erythema, ulceration, and necrosis, in order to ensure proper and early treatment

  Researchers will assess the nasal skin of preterm infants every 3-6 hours from the first day of providing NIRS till 14 days to determine the nasal damage score in both groups.

• change from the baseline pain score on Premature Infant Pain Profile (PIPP)

  It will be adopted from (Stevens et al., 1996). The Premature Infant Pain Profile (PIPP) is a biobehavioral observational technique used to quantify acute and procedure pain in premature infants. It assesses seven indicators: gestational age, behavioral state, increased heart rate, decreased oxygen saturation, forehead bulging, eye squeezing, and nasolabial furrows. Each indicator is scored on a four-point Likert scale, from 0 to 3. The total PIPP score, which is the sum of points for all seven indications, varies between 0 to 21. Higher scores imply more painful conduct. A number of 0-6 indicates no pain, 7-12 indicates mild to moderate pain, and a score more than 12 indicates severe pain.

  - Researchers will evaluate pain scores for preterm infants in both groups every 3-4 hours from the first day of providing NIRS till 14 days

Study Arms (2)

Control Group

NO INTERVENTION

: it will include thirty premature neonates who will receive the usual hospital care in accordance with hospital protocols, without any extra procedures or therapies.

Bundle group

EXPERIMENTAL

: it will include thirty premature neonates who will receive evidence-based guidelines on the prevention of nasal pressure injuries in form of a care bundle from the first day of providing NIRS till weaning.

Procedure: Non Invasive Respiratory Support bundle

Interventions

Non Invasive Respiratory Support bundle PROCEDURE

premature neonates who will receive evidence-based guidelines for prevention of nasal pressure injuries associated with non invasive respiratory support till weaning

Bundle group

Eligibility Criteria

• Age: 30 Weeks - 37 Weeks
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Preterm neonates receiving NIRS
• whose gestational ages ranges between 30 and 37 weeks, and both genders

You may not qualify if:

• all preterm neonates not receiving NIRS,
• have prior nasal trauma caused by tracheal intubation
• or Infants exhibiting evidence of nasal damage during the NIRS procedure,
• have upper respiratory abnormalities.
• preterm neonates who have undergone any type of surgery and had life-threatening congenital abnormalities.

Sponsors & Collaborators

• Kafrelsheikh University: lead

Study Sites (1)

Kafrelsheikh University

Kafr ash Shaykh, Kafr el-Sheikh Governorate, 33516, Egypt

RECRUITING

Study Officials

• Eman W Wardany, ass. professor

  pediatric nursing department, faculty of nursing kafrelsheikh univeristy

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Eman W abdelaal, Ass. Professor

CONTACT

01065407334; eman_wardany_2014@nur.kfs.edu.eg

Eman Wardany, ass. professor

CONTACT

01065407334; emanfadl2811@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: assistant professor of pediatric nursing

Study Record Dates

• First Submitted: October 9, 2024
• First Posted: October 15, 2024
• Study Start: August 1, 2024
• Primary Completion: December 30, 2024
• Study Completion: January 30, 2025
• Last Updated: October 15, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)