Ignite Creation Date:
2025-12-24 @ 3:43 PM
Ignite Modification Date:
2025-12-27 @ 4:03 AM
Study NCT ID:
NCT06992492
Status:
COMPLETED
Last Update Posted:
2025-12-22
First Post:
2025-05-05
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Vojta Reflex Versus Lung Squeezing Technique in Respiratory Distress Preterm Neonate
Sponsor:
Beni-Suef University
Organization:
Study Overview
Official Title:
Vojta Reflex Versus Lung Squeezing Technique In Preterm Neonate With Respiratory Distress Syndrome
Status:
COMPLETED
Status Verified Date:
2025-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
RDS
Brief Summary:
The goal of this clinical trial study is to find out the difference in the effect of vojta therapy and lung squeezing technique on preterm neonate with respiratory distress syndrome, to investigate the effect of vojta therapy and lung squeezing technique on Oxygen saturation and Respiratory rate, to evaluate the effect of vojta therapy and lung squeezing technique on (The length of hospital stay, Silverman Anderson score, Downe's score for respiratory distress syndrome (RDS) in preterm neonate. The main question it aims to answer is:
Is There a significant difference in the effect of vojta therapy and lung squeezing technique in preterm neonate with respiratory distress syndrome. Researchers will compare effect of vojta therapy and lung squeezing technique and control group. neonates diagnosed with respiratory distress syndrome aged from 28 to 36 weeks will be recruited for this study for three weeks from neonate intensive care unit.
neonates will receive conventional chest physical therapy for the control group and convetional chest physical therapy plus vojta therapy or lung squeezing technique for the two other groups twice daily for three weeks.
Is There a significant difference in the effect of vojta therapy and lung squeezing technique in preterm neonate with respiratory distress syndrome. Researchers will compare effect of vojta therapy and lung squeezing technique and control group. neonates diagnosed with respiratory distress syndrome aged from 28 to 36 weeks will be recruited for this study for three weeks from neonate intensive care unit.
neonates will receive conventional chest physical therapy for the control group and convetional chest physical therapy plus vojta therapy or lung squeezing technique for the two other groups twice daily for three weeks.
Detailed Description:
Type of study: randomized clinical trial. this study is a prospective interventional study one that will be conducted on 90 preterm neonates of both sexes from Neonatal Intensive care unit in Beni-Suef university, their gestational age ranged from 28 to 36 weeks and randomly divided into 3 equal groups:
1. study group (A) include preterm neonates with respiratory distress syndrome will receive vojta therapy along with conventional chest physical therapy (postural drainage, percussion and vibration) plus medical treatment with special emphasis on whether Surfactant therapy is given or not.
2. study group (B) include preterm neonates with respiratory distress syndrome will receive lung squeezing technique along with conventional chest physical therapy (postural drainage, percussion and vibration) plus medical treatment with special emphasis on whether Surfactant therapy is given or not.
3. control group (C) include preterm neonates with respiratory distress syndrome will receive conventional chest physical therapy (postural drainage, percussion and vibration) plus medical treatment only with special emphasis on whether Surfactant therapy is given or not.
Measurement procedures:
1.) Oxygen saturation and Respiratory rate: For the three study groups, the SpO2 and respiratory rate will be measured and noted before the reflex stimulation, at the end of stimulation II, at the end of stimulation IV and at 5, 15, 25 minutes after the whole series of stimulations, during each of the twice daily treatments. Throughout the whole procedure, the NBs were continuously monitored with a Vismo PVM-2701 monitor to assess any adverse effect, including hypoxemia (SpO2 \< 90) which would indicate suspension of the technique. physiotherapist followed the infants for three weeks.
Study variables: 1)RR = assessed by clinical evaluation of chest movement in one minute and SpO2 = measured with a pulse oximeter.
2\) Silverman Anderson score: The Silverman Andersen Respiratory Severity Score (RSS) evaluates five parameters of work of breathing and assigns an overall score with a patient breathing comfortably a "0" and a patient in severe respiratory distress a "10".
Score 0-3 = Mild respiratory distress - O2 by hood Score 4-6 = Moderate respiratory distress - CPAP Score \> 6 = Impending respiratory failure
3\) Downe's score for RDS: Downe score is an objective method to assess the severity of respiratory distress in newborns. It includes respiratory rate (RR), recessions, grunt, air entry and fractional oxygen requirement. Each parameter is score on a scale of 0, 1 and 2 with increasing severity. Total score ranges from 0 to 10.Score:
* \<4 = follow up.
* 4-7 = clinical respiratory distress; monitor arterial blood gases.
* 7 = respiratory failure
1. study group (A) include preterm neonates with respiratory distress syndrome will receive vojta therapy along with conventional chest physical therapy (postural drainage, percussion and vibration) plus medical treatment with special emphasis on whether Surfactant therapy is given or not.
2. study group (B) include preterm neonates with respiratory distress syndrome will receive lung squeezing technique along with conventional chest physical therapy (postural drainage, percussion and vibration) plus medical treatment with special emphasis on whether Surfactant therapy is given or not.
3. control group (C) include preterm neonates with respiratory distress syndrome will receive conventional chest physical therapy (postural drainage, percussion and vibration) plus medical treatment only with special emphasis on whether Surfactant therapy is given or not.
Measurement procedures:
1.) Oxygen saturation and Respiratory rate: For the three study groups, the SpO2 and respiratory rate will be measured and noted before the reflex stimulation, at the end of stimulation II, at the end of stimulation IV and at 5, 15, 25 minutes after the whole series of stimulations, during each of the twice daily treatments. Throughout the whole procedure, the NBs were continuously monitored with a Vismo PVM-2701 monitor to assess any adverse effect, including hypoxemia (SpO2 \< 90) which would indicate suspension of the technique. physiotherapist followed the infants for three weeks.
Study variables: 1)RR = assessed by clinical evaluation of chest movement in one minute and SpO2 = measured with a pulse oximeter.
2\) Silverman Anderson score: The Silverman Andersen Respiratory Severity Score (RSS) evaluates five parameters of work of breathing and assigns an overall score with a patient breathing comfortably a "0" and a patient in severe respiratory distress a "10".
Score 0-3 = Mild respiratory distress - O2 by hood Score 4-6 = Moderate respiratory distress - CPAP Score \> 6 = Impending respiratory failure
3\) Downe's score for RDS: Downe score is an objective method to assess the severity of respiratory distress in newborns. It includes respiratory rate (RR), recessions, grunt, air entry and fractional oxygen requirement. Each parameter is score on a scale of 0, 1 and 2 with increasing severity. Total score ranges from 0 to 10.Score:
* \<4 = follow up.
* 4-7 = clinical respiratory distress; monitor arterial blood gases.
* 7 = respiratory failure
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: