| 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
|
|
|
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
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: J988||Other specified respiratory disorders, |
|
|
Intervention / Comparator Agent
|
|
|
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 |