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

NCT ID: NCT06642285

Last Updated: 2024-10-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-08-01

Study Completion Date

2025-01-30

Brief Summary

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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

Detailed Description

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The researchers explained the study's aim, benefits, and procedures for participation, after that the parents of the neonates provided an informed consent. Over a one-week period, staff education programs regarding Evidence-Based Guidelines for non-invasive respiratory support will be conducted for NICU nursing staff. These sessions, lasting 15 to 20 minutes, will be held during regularly scheduled work hours, with four different sessions will offer throughout the day. The preterm neonates' characteristics and clinical data will be extracted from their hospital records for the two groups on the first day of admission for both groups prior to intervention to identify those who fulfilled the current study's inclusion criteria. Neonatal baseline data was collected from their records on the first day of admission for the two groups prior to intervention in order to identify neonates who meet the required criteria of the study. Then the participants were selected and divided randomly (using a simple random method) into two equal groups. One subject for the control group, one for the study group and so on, distributed the participants into two equivalent groups as fellow:

Control Group: Consisted of 30 premature neonates who will receive conventional hospital care with no additional interventions.

Study Group: Consisted of 30 premature neonates who will receive 6 evidence-based practices on the prevention of nasal pressure injuries as follows:

* Use an appropriately sized nasal interface device.
* The Use of Skin Barrier Products between nasal skin and nasal interface device
* Visually examining the preterm newborn every hour to ensure appropriate nasal interface position
* Once every 12-hour shift, the protective barrier and nasal device are briefly removed to allow for a full nasal skin examination
* Follow developmental care principles by repositioning the infant every three to four hours.
* Pain scores should be taken at least every three to four hours.

Conditions

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Mechanical Ventilation Complication Respiratory Distress Syndrome in Premature Infant

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Control Group

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

Group Type NO_INTERVENTION

No interventions assigned to this group

Bundle group

: 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.

Group Type EXPERIMENTAL

Non Invasive Respiratory Support bundle

Intervention Type PROCEDURE

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

Interventions

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Non Invasive Respiratory Support bundle

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

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* 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.
Minimum Eligible Age

30 Weeks

Maximum Eligible Age

37 Weeks

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Kafrelsheikh University

OTHER

Sponsor Role lead

Responsible Party

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Eman Wardany Abdelaal Mohamed

assistant professor of pediatric nursing

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Eman W Wardany, ass. professor

Role: PRINCIPAL_INVESTIGATOR

pediatric nursing department, faculty of nursing kafrelsheikh univeristy

Locations

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Kafrelsheikh University

Kafr ash Shaykh, Kafr el-Sheikh Governorate, Egypt

Site Status RECRUITING

Countries

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Egypt

Central Contacts

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Eman W abdelaal, Ass. Professor

Role: CONTACT

01065407334

Eman Wardany, ass. professor

Role: CONTACT

01065407334

Facility Contacts

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Kafrelsheikh University W Kafr Ash Shaykh, Ass. Professor

Role: primary

01065407334

Eman W Wardany, Ass. Professor

Role: backup

01065407334

Other Identifiers

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KafrelsheikhU4

Identifier Type: -

Identifier Source: org_study_id

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