Clinical trial NCT06992492: Vojta Reflex Versus Lung Squeezing Technique in Respiratory Distress Preterm Neonate
Official title: Vojta Reflex Versus Lung Squeezing Technique In Preterm Neonate With Respiratory Distress Syndrome
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Respiratory Distress Syndrome
Keywords: RDS
preterm neonates
Lead sponsor: Beni-Suef University
Sponsor class: OTHER
First posted: 2025-05-28
Enrollment: 90
Sex: ALL
Minimum age (years): 28
Maximum age (years): 36
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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 reflex rolling 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.
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

Eligibility criteria: Inclusion Criteria:

* preterm neonates will be:

  * Ranging from 28-36 weeks of gestation admitted to NICU with diagnosis of respiratory distress syndrome (RDS)on oxygen therapy.
  * Medically free from any other diseases except RDS.
  * On CPAP for respiratory support.

Exclusion Criteria:

* Preterm neonates who meet one of the following criteria will be excluded:

  * Musculoskeletal disorders
  * Encephalopathy
  * Recent surgery
  * Neonates with respiratory and cardiac congenital anomalies
  * mechanically ventilated
  * genetic syndromes
  * segmental or lobar collapse confirmed on chest X-ray
  * congenital malformation
  * asphyxia at birth
  * treatment with neurotrophic drugs
  * intraventricular hemorrhage \< 2 grade

Primary outcomes:
measure: Oxygen saturation
timeFrame: from enrollment for three weeks twice daily
measure: respiratory rate
timeFrame: from enrollment for three weeks twice daily
Secondary outcomes:
measure: Silverman Anderson score
timeFrame: at the start of the study and after the intervention once day for three weeks
measure: Downe's score for RDS
timeFrame: at the start of the study and after the intervention once day for three weeks
Other outcomes:
Locations:
city: Beni-Suef,Egypt
country: Egypt
facility: Beni_Suef university
Study officials:
affiliation: Beni-Suef University
name: Sherine H Mehani, professor
role: PRINCIPAL_INVESTIGATOR
References: