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CTRI Number  CTRI/2023/01/049323 [Registered on: 31/01/2023] Trial Registered Prospectively
Last Modified On: 30/01/2023
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Other 
Public Title of Study   EXAMINATION OF NEWBORN BABIES WITH RESPIRATORY DISTRESS IN HIGHER CENTRE. 
Scientific Title of Study   CLINICAL PROFILE OF NEONATES WITH RESPIRATORY DISTRESS IN TERTIARY CARE CENTRE:"A CROSS SECTIONAL STUDY"  
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  DR PRASAD NAYAK N 
Designation  Professor & Head of department 
Affiliation  Rohilkhand medical college & hospital 
Address  room no. 3004, department of paediatrics, rmch, bareilly

Bareilly
UTTAR PRADESH
243006
India 
Phone  9902909331  
Fax    
Email  prasad_nayak2001@yahoo.com  
 
Details of Contact Person
Scientific Query
 
Name  DR PRASAD NAYAK N 
Designation  Professor & Head of department 
Affiliation  Rohilkhand medical college & hospital 
Address  room no. 3004, department of paediatrics, rmch, bareilly


UTTAR PRADESH
243006
India 
Phone  9902909331  
Fax    
Email  prasad_nayak2001@yahoo.com  
 
Details of Contact Person
Public Query
 
Name  DR Mohd Shahjad 
Designation  JUNIOR RESIDENT 
Affiliation  Rohilkhand medical college & hospital 
Address  room no.51 P G Boys hostel rohilkhand medical college and hospital , bareilly.

Bareilly
UTTAR PRADESH
243006
India 
Phone  7017818867  
Fax    
Email  mansoori1515@gmail.com  
 
Source of Monetary or Material Support  
Rohilkhand medical college and hospital bareilly UP  
 
Primary Sponsor  
Name  Rohilkhand Medical College and Hospital Bareilly UP 
Address  Rohilkhand medical college & hospital, pilibhit bypass road, bareilly  
Type of Sponsor  Private medical college 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr prasad nayak N  Rohilkhand medical college and hospital bareilly  Room no 1174 , Pediatrics opd , rohilkhand medical college,Pilibhit bypass road , bareilly
Bareilly
UTTAR PRADESH 
9902909331

Prasad_nayak2001@yahoo.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
IEC BAREILLY  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: J988||Other specified respiratory disorders,  
 
Intervention / Comparator Agent  
Type  Name  Details 
 
Inclusion Criteria  
Age From  1.00 Day(s)
Age To  28.00 Day(s)
Gender  Both 
Details  1) Neonates with respiratory distress who were admitted in NICU within 28 days of life.
2) Neonates whose parents are willing to give consent. 
 
ExclusionCriteria 
Details  1) Neonates born with chromosomal disorders admitted to NICU.
2) Neonates born with inborn metabolic disorders admitted to NICU. 
 
Method of Generating Random Sequence   Other 
Method of Concealment   An Open list of random numbers 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
To determine the various etiology of the respiratory distress in neonates  1 week  
 
Secondary Outcome  
Outcome  TimePoints 
To study the spectrum of initial clinical presentation, progression and recovery of the respiratory distress with respect to scoring system.  1 week 
 
Target Sample Size   Total Sample Size="144"
Sample Size from India="144" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   N/A 
Date of First Enrollment (India)   05/02/2023 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="1"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   None yet 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary  
First breath is the most vital parameter in the beginning of a new life. Respiratory distress is a challenging problem and one of the most common cause of admission for neonatal intensive care unit (NICU) in both term and preterm infants1. Most of the causes of neonatal morbidity and mortality are preventable. Incidence of respiratory distress depends on various factors like gestational age, low birth weight, perinatal infections, and complications during pregnancy2. In a neonate, clinical diagnosis of respiratory distress is suspected if the respiratory rate is greater than 60 per minute in a quite resting baby, presence of grunting and/or there are inspiratory subcostal/intracostal retractions3. Presence of grunting, nasal flaring, retractions, tachypnea, decreased breath sounds are the important signs of respiratory distress4. Even in healthy term infants, oxygenation is impaired immediately after birth, and oxygen saturation gradually increases and exceeds 90% only at about 5 min5.
The severity of respiratory distress can be assessed by Downe’s scoring system6 and Silverman Anderson scoring system7. Respiratory distress syndrome, transient tachypnea of neonate, pneumonia, pneumothorax and air leaks, congenital pneumonia, Meconium aspiration syndrome, Tracheo-esophageal fistula, Diaphragmatic hernia are the important causes of respiratory distress in neonates8.
 1

Other uncommon respiratory causes include congenital lobar emphysema, accessory or
 
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