Effect of Prolonged Slow Expiration Technique on Blood Gases Among Pneumatic Neonates

NCT ID: NCT05781464

Last Updated: 2023-11-29

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

COMPLETED

Clinical Phase

NA

Total Enrollment

32 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-04-01

Study Completion Date

2023-11-17

Brief Summary

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Pneumonia is a medical condition that, if not treated promptly, can lead to life- threatening complications. The prolonged slow expiration technique is a new type of chest physiotherapy that helps infants discharge bronchial secretions which accumulated due to pneumonia.

Detailed Description

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Pneumonia is an infective lung condition that is one of the most common risk factors for neonatal death. Pulmonary infections, most common caused by anaerobic bacterial infection, result in the accumulation of pus in the pleural cavity. Preterms, neonates with respiratory infections, and underdeveloped lungs all require the use of a prolonged slow expiration technique.

Prolonged slow expiration technique is the only chest clearance technique that provides both effective clearance and a soothing effect. Another recommendation for this technique is lack of application of emerging techniques of respiratory physiotherapy. Although the technique is effective, it is rarely in practice over the conventional methods of chest physiotherapy.

During prolonged slow expiration, intrathoracic pressure gradually rises due to thoracoabdominal compression, preventing bronchial collapse and flow disruption that occurs during forced expirations.

Conditions

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Pneumonia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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Traditional chest physiotherapy

This group receives traditional chest physiotherapy that include postural drainage, percussion and vibration ( manually or by a vibrator) in each session which is twice daily from admission to neonatal intensive care unit till discharge

Group Type PLACEBO_COMPARATOR

Traditional chest physiotherapy

Intervention Type PROCEDURE

Postural drainage: the patient is positioned in postural drainage so that gravity had the maximum effect on the lung segment that needed to be drained, all lung zones are emphasised in positional initiatives for babies.

Percussion is the rhythmic striking of the chest wall with cupped hands for 1 to 2 minutes at a time.

Vibration is performed by placing fingers on the chest wall over the segment being drained and isometrically contracting the forearm and hand muscles to produce a vibratory motion.

Vibration is accomplished either through manual vibratory motion of the therapist's fingers on the infant's chest wall or through the use of a mechanical vibrator ( Foreo vibrator).

Prolonged slow expiration technique and traditional chest physiotherapy

This group receives traditional chest physiotherapy that include postural drainage, percussion and vibration ( manually or by a vibrator) plus prolonged slow expiration technique in each session which is twice daily from admission in neonatal intensive care unit till discharge.

Group Type ACTIVE_COMPARATOR

Traditional chest physiotherapy

Intervention Type PROCEDURE

Postural drainage: the patient is positioned in postural drainage so that gravity had the maximum effect on the lung segment that needed to be drained, all lung zones are emphasised in positional initiatives for babies.

Percussion is the rhythmic striking of the chest wall with cupped hands for 1 to 2 minutes at a time.

Vibration is performed by placing fingers on the chest wall over the segment being drained and isometrically contracting the forearm and hand muscles to produce a vibratory motion.

Vibration is accomplished either through manual vibratory motion of the therapist's fingers on the infant's chest wall or through the use of a mechanical vibrator ( Foreo vibrator).

Prolonged slow expiration technique

Intervention Type PROCEDURE

The therapist places one hand on the thorax below the suprasternal notch and the other hand over the upper abdomen while the neonate is supine. Both hands will have hypothenar contact with the thorax and abdomen. At the end of the expiratory phase, the therapist places a compression force with both hands. Compression at the end of expiration with hypothenar eminence is kept for 2 or 3 breathing cycles. This technique is repeated several times, with a rest time between applications of about 5 or 10 spontaneous breaths.

Interventions

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Traditional chest physiotherapy

Postural drainage: the patient is positioned in postural drainage so that gravity had the maximum effect on the lung segment that needed to be drained, all lung zones are emphasised in positional initiatives for babies.

Percussion is the rhythmic striking of the chest wall with cupped hands for 1 to 2 minutes at a time.

Vibration is performed by placing fingers on the chest wall over the segment being drained and isometrically contracting the forearm and hand muscles to produce a vibratory motion.

Vibration is accomplished either through manual vibratory motion of the therapist's fingers on the infant's chest wall or through the use of a mechanical vibrator ( Foreo vibrator).

Intervention Type PROCEDURE

Prolonged slow expiration technique

The therapist places one hand on the thorax below the suprasternal notch and the other hand over the upper abdomen while the neonate is supine. Both hands will have hypothenar contact with the thorax and abdomen. At the end of the expiratory phase, the therapist places a compression force with both hands. Compression at the end of expiration with hypothenar eminence is kept for 2 or 3 breathing cycles. This technique is repeated several times, with a rest time between applications of about 5 or 10 spontaneous breaths.

Intervention Type PROCEDURE

Other Intervention Names

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Postural drainage Percussion Vibration Foreo Vibrator

Eligibility Criteria

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Inclusion Criteria

* Age since birth till 2 months
* Clinical findings of pneumonia: tachypnea, chest recession, fever, cyanosis and cough
* Radiological diagnosis of pneumonia (x-ray): lober or segmental consolidation, nodular or coarse patchy infiltration, diffuse haziness and air bronchogram.
* Neonates on oxygen therapy.

Exclusion Criteria

* Neonates with congenital cardiopathy.
* Neonates with surgical incision in thorax or abdomen.
* Neonates with neurological intervention.
* Neonates with obstruction of upper air way.
* Neonates with gastroesophageal reflux and laryngeal affection.
Minimum Eligible Age

1 Day

Maximum Eligible Age

2 Months

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Cairo University

OTHER

Sponsor Role lead

Responsible Party

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Moshira Mohamed Metwally

Physical therapist

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Elham Salem

Role: STUDY_CHAIR

Cairo University

Locations

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Faculty of physical Therapy

Giza, , Egypt

Site Status

Countries

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Egypt

References

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Lievens L, Vandenplas Y, Vanlaethem S, Van Ginderdeuren F. Prolonged Slow Expiration Technique and Gastroesophageal Reflux in Infants Under the Age of 1 Year. Front Pediatr. 2021 Sep 8;9:722452. doi: 10.3389/fped.2021.722452. eCollection 2021.

Reference Type BACKGROUND
PMID: 34568241 (View on PubMed)

Gomes EL, Postiaux G, Medeiros DR, Monteiro KK, Sampaio LM, Costa D. Chest physical therapy is effective in reducing the clinical score in bronchiolitis: randomized controlled trial. Rev Bras Fisioter. 2012 Jun;16(3):241-7. doi: 10.1590/s1413-35552012005000018. Epub 2012 Apr 12.

Reference Type BACKGROUND
PMID: 22499404 (View on PubMed)

Other Identifiers

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NoP.T.REC/012/003676

Identifier Type: -

Identifier Source: org_study_id