| CTRI Number |
CTRI/2017/09/009653 [Registered on: 05/09/2017] Trial Registered Prospectively |
| Last Modified On: |
04/09/2017 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Cohort Study |
| Study Design |
Other |
|
Public Title of Study
|
Normal values vital parameters in stable VLBW neonates |
|
Scientific Title of Study
|
Normative values of hemodynamic parameters in stable VLBW neonates during first month of life |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Manoj Modi |
| Designation |
Dr |
| Affiliation |
Sir Ganga Ram hospital |
| Address |
Department of Neonatology
Sir Ganga Ram hospital
Rajinder nagar
New Delhi
DELHI
110060
India |
| Phone |
|
| Fax |
|
| Email |
drmanojmodi@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Manoj Modi |
| Designation |
Dr |
| Affiliation |
Sir Ganga Ram hospital |
| Address |
Department of Neonatology
Sir Ganga Ram hospital
Rajinder nagar
New Delhi
DELHI
110060
India |
| Phone |
|
| Fax |
|
| Email |
drmanojmodi@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Manoj Modi |
| Designation |
Dr |
| Affiliation |
Sir Ganga Ram hospital |
| Address |
Department of Neonatology
Sir Ganga Ram hospital
Rajinder nagar
New Delhi
DELHI
110049
India |
| Phone |
|
| Fax |
|
| Email |
drmanojmodi@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Manoj Modi |
| Address |
Sir Ganga Ram Hospital
Rajinder nagar
New Delhi |
| Type of Sponsor |
Other [Self] |
|
|
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 |
| Manoj Modi |
Sir Ganga Ram hospital |
Department of Neonatology
Sir Ganga Ram hospital
Rajinder Nagar
New Delhi
DELHI |
9873266331
drmanojmodi@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Ethics Committee Sir Ganga Ram Hospital |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
stable very low birth weight neonates, |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
1.00 Day(s) |
| Age To |
30.00 Day(s) |
| Gender |
Both |
| Details |
stable very low birth weight neonates |
|
| ExclusionCriteria |
| Details |
1 - Perinatal asphyxia defined as 5 min APGAR <3
2 - Neonates on mechanical ventilation with mean airway pressure (MAP) >15 mbar
3 - Neonates with congenital heart disease
4 - Neonates with hemodynamically significant patent ductus atreriosus (PDA): Duct size >1.5 mm with unrestricted laminar flow plus any one of following: turbulence in MPA, diastolic reversal in post ductal aorta, LA/Ao ratio >1.5
5 - Neonates with a diagnosis of persistent pulmonary hypertension (PPHN)
6 - Neonates with gross congenital malformations
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| -BP measurement during first month of life |
day of life 1, 2, 3, 4, 5, 6, 7, 14, 21, 28 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Perfusion Index |
Day 1, 3, 7, 14, 28 |
|
|
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)
|
30/09/2017 |
| 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 Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
under recruitment stage |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
The objective of this study is to evaluate gestation specific normative data of non-invasive BP and PI in
hemodynamically stable VLBW neonates at day during first month of life. All
neonates will be enrolled at time of admission to NICU. Demographic characteristics
and antenatal details of enrolled infants, including maternal hypertension,
fetal growth restriction, umbilical artery Doppler abnormality, chorioamnitis,
antenatal steroid cover, and mode of delivery will be recorded on a proforma.
Assessment of vital parameters will be made once in a day by single research
nurse, daily during first week, and weekly thereafter till discharge. At each assessment, heart rate, oxygen
saturation (SPO2), capillary refill time (CRT), BP, pulse volume, perfusion
index (PI) and central and peripheral temperature will be recorded. Since
information on gestation specific longitudinal data is not available in the
published literature, we are planning to enroll at least 30
neonates in each gestation category. Data will be presented as mean (SD) or median (IQR)
as per distribution of data. |