## Protocol Section
### Identification Module
**NCT ID:** NCT06428916

**Brief Title:** Facilitated Tucking Position During Endotracheal Suctioning

**Official Title:** The Effect of Facilitated Tucking Position During Endotracheal Suctioning on Physiological Measurement and Behavioral Responses of the Preterm Neonates

#### Organization Study ID Info
**ID:** KafrelsheikhU2
#### Organization
**Class:** OTHER
**Full Name:** Kafrelsheikh University
### Status Module
#### Completion Date
**Date:** 2023-07-30

**Type:** ACTUAL

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-24

**Type:** ACTUAL

**Last Update Submit Date:** 2024-05-22

**Overall Status:** COMPLETED

#### Primary Completion Date
**Date:** 2023-05-01

**Type:** ACTUAL

#### Start Date
**Date:** 2022-12-01

**Type:** ACTUAL

**Status Verified Date:** 2024-05

#### Study First Post Date
**Date:** 2024-05-24
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-14
**Study First Submit QC Date:** 2024-05-22
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** OTHER

**Name:** Kafrelsheikh University

#### Responsible Party

**Investigator Affiliation:** Kafrelsheikh University

**Investigator Full Name:** Eman Wardany Abdelaal Mohamed

**Investigator Title:** assistant professor of pediatric nursing

**Type:** PRINCIPAL_INVESTIGATOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

### Description Module

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

### Conditions Module

**Conditions:**

- Respiratory Distress Syndrome

**Keywords:**

- Physiological measurement

- Behavioral Responses of the Preterm Neonates

- Facilitated Tucking Position

- Endotracheal Suctioning

### Design Module

#### Design Info

**Allocation:** RANDOMIZED

**Intervention Model:** PARALLEL

##### Masking Info

**Masking:** SINGLE

**Who Masked:**

- INVESTIGATOR

**Primary Purpose:** SUPPORTIVE_CARE

#### Enrollment Info

**Count:** 40

**Type:** ACTUAL

**Phases:**

- NA

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

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

**Intervention Names:**

- Procedure: tucking position during endotracheal suctioning

**Label:** Study Group

**Type:** EXPERIMENTAL

#### Arm Group 2

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

**Label:** Control group

**Type:** NO_INTERVENTION

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Study Group

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

**Name:** tucking position during endotracheal suctioning

**Type:** PROCEDURE

### Outcomes Module

#### Primary Outcomes

**Description:** 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)

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

**Time Frame:** during procedural and immediately after procedure

**Description:** 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)

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

**Time Frame:** during procedural and immediately after procedure

**Description:** 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)

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

**Time Frame:** during procedural and immediately after procedure

#### Secondary Outcomes

**Description:** This scale was adopted from Anderson et al.(1990) to assess the behavioral organization of preterm neonates. Neonates' behavioral states are assessed by observing their respiratory regularity, opening or closing of the eyes, limb and trunk activity, and the intensity of crying. Based on the observations, the scale will differentiate 12 behavioral states, including; regular quiet sleep (1), irregular quiet sleep (2), active sleep (3), very active sleep (4), drowsy (5), alert inactivity (6), quite awake (7), active awake (8), very active awake (9), fussing (10), crying (11) and hard crying (12). Scores from 1 to 5 indicate that the neonate is sleeping. Scores from 6 to 8 indicate that the neonate is awake and calm. Scores from 9 to 12 indicate that the neonate is in a state of restless activity or fussiness, which takes substantial energy

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

**Time Frame:** during procedural and immediately after procedure

### Eligibility Module

**Eligibility Criteria:** Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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.

**Healthy Volunteers:** True

**Maximum Age:** 36 Weeks

**Minimum Age:** 32 Weeks

**Sex:** ALL

**Standard Ages:**

- CHILD

### Contacts Locations Module

#### Locations

**Location 1:**

**City:** Kafr Ash Shaykh

**Country:** Egypt

**Facility:** Kafrelsheikh University

**State:** Kafr el-Sheikh

**Zip:** 33516

### IPD Sharing Statement Module

**IPD Sharing:** NO

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000008171

- Term: Lung Diseases

- ID: D000012140

- Term: Respiratory Tract Diseases

- ID: D000012120

- Term: Respiration Disorders

- ID: D000007235

- Term: Infant, Premature, Diseases

- ID: D000007232

- Term: Infant, Newborn, Diseases

### Condition Browse Module - Browse Branches

- Abbrev: BC23

- Name: Symptoms and General Pathology

- Abbrev: All

- Name: All Conditions

- Abbrev: BXS

- Name: Urinary Tract, Sexual Organs, and Pregnancy Conditions

- Abbrev: BC08

- Name: Respiratory Tract (Lung and Bronchial) Diseases

- Abbrev: BC16

- Name: Diseases and Abnormalities at or Before Birth

- Abbrev: Rare

- Name: Rare Diseases

### Condition Browse Module - Browse Leaves

- ID: M16355

- Name: Syndrome

- Relevance: LOW

- As Found: Unknown

- ID: M25869

- Name: Premature Birth

- Relevance: LOW

- As Found: Unknown

- ID: M14965

- Name: Respiratory Distress Syndrome

- Relevance: HIGH

- As Found: Respiratory Distress Syndrome

- ID: M14964

- Name: Respiratory Distress Syndrome, Newborn

- Relevance: HIGH

- As Found: Respiratory Distress Syndrome

- ID: M11168

- Name: Lung Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M14977

- Name: Respiratory Tract Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M14957

- Name: Respiration Disorders

- Relevance: LOW

- As Found: Unknown

- ID: M10279

- Name: Infant, Premature, Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M10276

- Name: Infant, Newborn, Diseases

- Relevance: LOW

- As Found: Unknown

- ID: T4927

- Name: Respiratory Distress Syndrome, Infant

- Relevance: HIGH

- As Found: Respiratory Distress Syndrome

- ID: T192

- Name: Acute Respiratory Distress Syndrome

- Relevance: HIGH

- As Found: Respiratory Distress Syndrome

### Condition Browse Module - Meshes

- ID: D000012128

- Term: Respiratory Distress Syndrome

- ID: D000012127

- Term: Respiratory Distress Syndrome, Newborn

### Misc Info Module

- Version Holder: 2024-05-31
