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

K

Kafrelsheikh University

Status

Enrolling

Conditions

Respiratory Distress Syndrome in Premature Infant
Mechanical Ventilation Complication

Treatments

Procedure: Non Invasive Respiratory Support bundle

Study type

Interventional

Funder types

Other

Identifiers

NCT06642285
KafrelsheikhU4

Details and patient eligibility

About

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

Full description

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.

Enrollment

30 estimated patients

Sex

All

Ages

30 to 37 weeks old

Volunteers

Accepts Healthy Volunteers

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.

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

30 participants in 2 patient groups

Control Group
No Intervention group
Description:
: 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 group
Description:
: 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.
Treatment:
Procedure: Non Invasive Respiratory Support bundle

Trial contacts and locations

1

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Central trial contact

Eman Wardany, ass. professor; Eman W abdelaal, Ass. Professor

Data sourced from clinicaltrials.gov

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