NCT06428916

Brief Summary

Aim of the present study The present study will aimed to determine the effect of facilitated tucking position during endotracheal suctioning on physiological criteria and behavioural responses of the preterm neonates. Research Hypotheses

  1. 1.Preterm neonates who receive facilitated tucking position during endotracheal suctioning exhibit more stable physiological criteria than those who do not.
  2. 2.Preterm neonates who receive facilitated tucking position during endotracheal suctioning exhibit more stable behavioral responses than those who do not.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Dec 2022

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2022

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2023

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 30, 2023

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

May 14, 2024

Completed
10 days until next milestone

First Posted

Study publicly available on registry

May 24, 2024

Completed
Last Updated

May 24, 2024

Status Verified

May 1, 2024

Enrollment Period

5 months

First QC Date

May 14, 2024

Last Update Submit

May 22, 2024

Conditions

Keywords

Physiological measurementBehavioral Responses of the Preterm NeonatesFacilitated Tucking PositionEndotracheal Suctioning

Outcome Measures

Primary Outcomes (3)

  • Change from baseline of heart rate of preterm neonates on Neonates' Physiological Assessment Tool during and immediately following the endotracheal suction procedure

    Neonates' Physiological Assessment Tool was developed by researchers after a review of relevant literature to assess Physiological Parameters of preterm neonates as Heart Rate (HR)

    during procedural and immediately after procedure

  • Change from baseline of Respiratory Rate of preterm neonates on Neonates' Physiological Assessment Tool during and immediately following the endotracheal suction procedure

    Neonates' Physiological Assessment Tool was developed by researchers after a review of relevant literature to assess Physiological Parameters of preterm neonates as Respiratory Rate (RR)

    during procedural and immediately after procedure

  • Change from baseline of oxygen saturation in blood of preterm neonates on Neonates' Physiological Assessment Tool during and immediately following the endotracheal suction procedure

    Neonates' Physiological Assessment Tool was developed by researchers after a review of relevant literature to assess Physiological Parameters of preterm neonates as oxygen saturation in blood(SPO2)

    during procedural and immediately after procedure

Secondary Outcomes (1)

  • change of baseline of Neonates' behavioral states on Anderson Behavioral State Scale during and immediately following the endotracheal suction procedure

    during procedural and immediately after procedure

Study Arms (2)

Study Group

EXPERIMENTAL

Consisted of 20 neonates who will receive tucking position during endotracheal suctioning

Procedure: tucking position during endotracheal suctioning

Control group

NO INTERVENTION

Consisted of 20 neonates who will receive routine care during Endotracheal suctioning

Interventions

, the staff nurse will perform the endotracheal suctioning while the researcher will carried out the intervention

Study Group

Eligibility Criteria

Age32 Weeks - 36 Weeks
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • Gestational age between 32 and 36 weeks, weight 1200 grams or greater.
  • Postnatal age: two days after delivery to allow for resolution of analgesia or anesthesia received by their mothers during labor.
  • Have endotracheal intubation.

You may not qualify if:

  • Preterm neonates who have congenital anomalies or neurological malformations, intracranial hemorrhage, seizures.
  • Preterm neonates who received sedatives within four hours before the intervention
  • Preterm neonates who exposed to any uncomfortable procedure for at least 30 minutes prior to the intervention.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kafrelsheikh University

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

Location

MeSH Terms

Conditions

Respiratory Distress Syndrome

Condition Hierarchy (Ancestors)

Lung DiseasesRespiratory Tract DiseasesRespiration Disorders

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
assistant professor of pediatric nursing

Study Record Dates

First Submitted

May 14, 2024

First Posted

May 24, 2024

Study Start

December 1, 2022

Primary Completion

May 1, 2023

Study Completion

July 30, 2023

Last Updated

May 24, 2024

Record last verified: 2024-05

Data Sharing

IPD Sharing
Will not share

Locations