Neonatal Respiratory Distress Syndrome Clinical Trial
Official title:
Impact of Neurophysiological Facilitation of Respiration in Preterm Neonates Admitted in Level II Neonatal Intensive Care Unit: A Randomized Controlled Trail
Background: Respiratory distress syndrome (RDS) or Neonatal respiratory distress syndrome
(NRDS) is characterized by pulmonary insufficiency, in preterm neonates and is the major
cause of death in preterm. Neurophysiological facilitation of Respiration (NFR) technique
produce reflex respiratory movement response, as it involves application of external
proprioceptive and tactile stimuli that is known to alter the rate and depth of breathing
Aim: This study is being conducted to determine the effectiveness of NFR in preterm neonates
diagnosed with RDS.
Methods: In this study 30 preterm (1- 8 days) neonates diagnosed with Respiratory Distress
Syndrome will be taken and assigned into two groups,Experimental group (n=15) and control
group (n=15). Neonates within eight days of birth those born before 37 weeks of gestation,
diagnosed with RDS were included in the study. Neonate undergone recent surgery or congenital
disorder, or medically unstable will be excluded.
Data analysis: Normality of the collected data will be analyzed with either two of the
normality test i.e. Shapiro Wilk test and Kolmogorov Smirnov test based on sample size.
Demographics characteristic of collected sample will be expressed in a mean standard
deviation or median and range based normality. For Between group comparison Independent t
test or Mann Whitney U test and for within group comparison paired t test or Wilcoxon singed
ranked test will be used.
Status | Not yet recruiting |
Enrollment | 30 |
Est. completion date | January 20, 2021 |
Est. primary completion date | January 5, 2021 |
Accepts healthy volunteers | No |
Gender | All |
Age group | N/A to 8 Days |
Eligibility |
Inclusion Criteria: - Neonates within eight days of birth Neonates born before 37 weeks of gestation Neonates diagnosed with Respiratory distress syndrome Exclusion Criteria: - Medically unstable neonates Neonates who undergone recent surgery or congenital disorder |
Country | Name | City | State |
---|---|---|---|
India | Neonatal Intensive Care Unit | Ambala | Haryana |
Lead Sponsor | Collaborator |
---|---|
Asir John Samuel |
India,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Respiratory Rate (RR) | RR will be assessed from the monitor display (On 1st day prior to intervention and on the 5th day after intervention) | Change in RR measured between baseline and 5th day post intervention | |
Primary | Heart Rate (HR) | HR will be assessed from the monitor display (On 1st day prior to intervention and on the 5th day after intervention) | Change in HR measured between baseline and 5th day post intervention | |
Primary | Saturation of Peripheral Oxygen (SPO2) | SPO2 will be assessed from the monitor display (On 1st day prior to intervention and on the 5th day after intervention) | Change in SPO2 measured between baseline and 5th day post intervention | |
Primary | Chest Expansion (CE) | CE will be measured with the help of measuring tape at nipple level (On 1st day prior to intervention and on the 5th day after intervention) | Change in CE measured between baseline and 5th day post intervention |
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