| CTRI Number |
CTRI/2024/01/061083 [Registered on: 03/01/2024] Trial Registered Prospectively |
| Last Modified On: |
03/01/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Prospective observational study |
| Study Design |
Other |
|
Public Title of Study
|
Trend of Morbidity Observed In Late Preterm Neonates |
|
Scientific Title of Study
|
Morbidity Pattern In Late Preterm Neonates |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
S RASHMITHA |
| Designation |
Junior resident,Department of Paediatrics |
| Affiliation |
KASTURBA MEDCAL COLLEGE MANIPAL |
| Address |
1ST FLOOR,DEPARTMENT OF NEONATOLOGY AND DEPARTMENT OF PAEDIATRICS,KASTURBA MEDICAL COLLEGE,MANIPAL,KARNATAKA.
Udupi
KARNATAKA
576104
India |
| Phone |
8940694057 |
| Fax |
|
| Email |
rashmithafeb1997@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DR.LESLIE EDWARD LEWIS |
| Designation |
PROFESSOR AND HEAD OF THE DEPARTMENT |
| Affiliation |
KASTURBA MEDCAL COLLEGE MANIPAL |
| Address |
DEPARTMENT OF NEONATOLOGY AND DEPARTMENT OF PAEDIATRICS
Udupi
KARNATAKA
576104
India |
| Phone |
8940694057 |
| Fax |
|
| Email |
leslie.lewis@manipal.edu |
|
Details of Contact Person
Public Query
|
| Name |
S RASHMITHA |
| Designation |
Junior resident |
| Affiliation |
KASTURBA MEDCAL COLLEGE MANIPAL |
| Address |
1ST FLOOR,DEPARTMENT OF NEONATOLOGY AND DEPARTMENT OF PAEDIATRICS,KASTURBA MEDICAL COLLEGE,MANIPAL,KARNATAKA.
Udupi
KARNATAKA
576104
India |
| Phone |
8940694057 |
| Fax |
|
| Email |
rashmithafeb1997@gmail.com |
|
|
Source of Monetary or Material Support
|
| INSTITUTIONAL-KASTURBA MEDICAL COLLEGE,MANIPAL,KARNATAKA. |
|
|
Primary Sponsor
|
| Name |
Manipal Academy Of Higher Education |
| Address |
Manipal Academy Of Higher Education,MANIPAL,UDUPI DISTRICT,KARNATAKA |
| 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 RASHMITHA S |
KMC MANIPAL |
DEPRTMENT OF PAEDIATRICS AND DEPARTMENT OF NEONATOLOGY
KMC MANIPAL
Udupi
KARNATAKA |
8940694057
rashmithafeb1997@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| KASTURBA MEDICAL COLLEGE AND KASTURBA HOSPITAL INSTITUTIONAL ETHICS COMMITTEE 2 |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
, (1) ICD-10 Condition: V00-Y99||External causes of morbidity, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
8.50 Month(s) |
| Age To |
9.80 Month(s) |
| Gender |
Both |
| Details |
The study will include all liveborn late preterm born between July 2023 and June 2024 |
|
| ExclusionCriteria |
| Details |
Neonates with evident congenital anomalies
Late preterm neonates who are discharged against medical advice
Neonates whose parents refuse to participate in the study |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Incidence of RDS and requirement of bag and mask/mechanical
ventilation.Incidence and severity of hyperbilirubinemia ,incidence of hypothermia, hypoglycemia,
hypocalcemia and other ,metabolic abnormalities,incidence of sepsis. |
From December 2023 to November 2024 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Maternal risk factors leading to late preterm birth,time taken to establish
breast feeding,duration of hospital stay and number of neonates requiring readmissions. |
From December 2023 to November2024 |
|
|
Target Sample Size
|
Total Sample Size="300"
Sample Size from India="300"
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)
|
25/01/2024 |
| 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="0"
Months="10"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Late preterm neonates are more susceptible to develop respiratory and metabolic complications. Aim of the study is to determine the morbidity pattern among late preterm neonates In a prospective study “Morbidity and mortality pattern in late preterm neonates in tertiary care hospital
in Jammu and Kashmir,Northern Indiaâ€,all live born late preterm neonates delivered in G.B Pant
General Hospital were included in the study.Out of total 4100 deliveries,3100 were term and 475 were
late preterm. Weight for gestation, overall morbidity, incidence of RDS, need for mechanical
ventilation, hypoglycemia, hyperbilirubinemia were the variables observed.It was found that late
preterms had higher mobidity and mortality when compared to term neonates and hyperbilirubinemia
was the most common morbidity observed.
In a prospective study,â€Morbidity profile and immediate outcome of late preterm neonates compared
to term neonates in a rural tertiary care hospital of Gujarat†by Manish Rasania ,Prasad Muley it was
observed that late preterm neonates had higher risk of sepsis and respiratory morbidities when
compared to term neonates. |