| CTRI Number |
CTRI/2024/10/075085 [Registered on: 10/10/2024] Trial Registered Prospectively |
| Last Modified On: |
29/09/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cohort Study |
| Study Design |
Other |
|
Public Title of Study
|
comparing death and problems faced by babies born less than 800 grams between two periods (2017-2020 and 2021-2023) in a high quality newborn intensive care unit |
|
Scientific Title of Study
|
Comparative analysis of short term outcomes in Extremely Low Birth Weight infants <800grams (micro-preemies) in a tertiary care NICU between two time periods : a retrospective cohort 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 Meena Kadiyala |
| Designation |
DM Neonatology resident |
| Affiliation |
Chettinad Hospital and Research Institute |
| Address |
Department of Neonatology,
Chettinad Hospital and Research Institute, Rajiv Gandhi Salai, SH 49A, Kelambakkam, Chengalpattu district, Kancheepuram, Tamil Nadu, India
Kancheepuram
TAMIL NADU
603103
India |
| Phone |
8501077299 |
| Fax |
|
| Email |
kadiyalameena@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Giridhar Sethuraman |
| Designation |
Professor of Neonatology |
| Affiliation |
Chettinad Hospital and Research Institute |
| Address |
Department of Neonatology,
Chettinad Hospital and Research Institute, Rajiv Gandhi Salai, SH 49A, Kelambakkam, Chengalpattu district, Kancheepuram, Tamil Nadu, India
Kancheepuram
TAMIL NADU
603103
India |
| Phone |
9841027228 |
| Fax |
|
| Email |
giridharsethu@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Giridhar Sethuraman |
| Designation |
Professor of Neonatology |
| Affiliation |
Chettinad Hospital and Research Institute |
| Address |
Department of Neonatology,
Chettinad Hospital and Research Institute, Rajiv Gandhi Salai, SH 49A, Kelambakkam, Chengalpattu district, Kancheepuram, Tamil Nadu, India
Kancheepuram
TAMIL NADU
603103
India |
| Phone |
9841027228 |
| Fax |
|
| Email |
giridharsethu@gmail.com |
|
|
Source of Monetary or Material Support
|
| Chettinad Hospital and Research Institute, Rajiv Gandhi Salai, SH 49A, Kelambakkam, Chengalpattu district, Kancheepuram, Tamil Nadu, India- 603103. |
|
|
Primary Sponsor
|
| Name |
Dr Meena kadiyala |
| Address |
Department of Neonatology,
Chettinad Hospital and Research Institute, Rajiv Gandhi Salai, SH 49A, Kelambakkam, Chengalpattu district, Kancheepuram, Tamil Nadu, India |
| 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 |
| Dr Meena kadiyala |
Chettinad Hospital and Research Institute |
Department of Neonatology, block-c, ground floor
Kancheepuram
TAMIL NADU |
8501077299
kadiyalameena@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Human Ethics Committee for Student Research (CARE IHEC-I) |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: P84||Other problems with newborn, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
NIL |
NIL |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
0.00 Day(s) |
| Age To |
6.00 Month(s) |
| Gender |
Both |
| Details |
Preterm neonates with birth weight less than 800 grams (micro-preemie) and confirmed gestational age of more than 23 0/7 weeks given full NICU care after shared decision making of obstetric/neonatal team with family of baby will be included in the study.
|
|
| ExclusionCriteria |
| Details |
Preterm neonates with lethal or complicated malformations , chromosomal anomalies.
Death/discontinuation of treatment within 12 hours of delivery will be excluded from the study.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Proportion of neonates who had survived till discharge (survival rates)
|
Birth to discharge
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Short term morbidities like,
Respiratory Distress Syndrome [RDS]
Hemodynamically significant Patent ductus arteriosus [hs-PDA]
Necrotizing Enterocolitis [NEC] (bell stage II or greater)
Intraventricular Hemorrhage [IVH] grade ≥ II
Periventricular leukomalacia [PVL]
Pulmonary hemorrhage
Any sepsis [culture proven , screen positive, clinical sepsis]
Dys-electrolytemia
Moderate to severe bronchopulmonary dysplasia [BPD]
Retinopathy Of Prematurity [ROP] during hospital stay
Osteopenia of prematurity
Neonatal cholestasis
Anaemia of prematurity
Coagulopathy
Thrombocytopenia
|
Birth to discharge |
Requirement of Therapeutic modalities like,
Ventilation
Surfactant replacement therapy
Total parenteral nutrition [TPN]
Antibiotics for sepsis
PDA medical management / PDA ligation
Blood products transfusion (packed red cells, fresh frozen plasma)
Steroids for BPD
Laser therapy or intravitreal injections for ROP Â
|
Birth to discharge |
Feeding related parameters like,
Feed intolerance with number of feed interruptions
Time to reach full enteral feeds
Time to start paladai feeds and to reach full paladai feeds
Probiotic usage
|
Birth to discharge |
Age (in days) for discharge from the hospital in survivors
|
Birth to discharge |
|
|
Target Sample Size
|
Total Sample Size="206"
Sample Size from India="206"
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)
|
15/10/2024 |
| 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="2"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| 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 - YES
- What data in particular will be shared?
Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).
- What additional supporting information will be shared?
Response - Study Protocol
Response - Statistical Analysis Plan
- Who will be able to view these files?
Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.
- For what types of analyses will this data be available?
Response - To achieve aims in the approved proposal.
- By what mechanism will data be made available?
Response (Others) -
- For how long will this data be available start date provided 30-12-2025 and end date provided 30-12-2028?
Response - Beginning 9 months and ending 36 months following article publication.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
|
|
Brief Summary
|
ELBW neonates especially
micro preemies (with birth weight <800 gm) constitute a very vulnerable
subgroup of neonates, who are predisposed to higher rates of mortality and
morbidities. If anticipated and managed timely, long-term survival of these
neonates can be achieved. Although there has been improvement in survival of
ELBW infants in developed nations, the survival of ELBW neonates in developing
countries remains suboptimal due to lack of required infrastructure and good
quality perinatal services. There is paucity of literature regarding mortality
and morbidity data in LMICs. Data from a recent Cochrane review in 2021
suggests that for ELBW neonates,
the survival in LI, LMI, and UMI countries was 18% (11% - 28%), 28% (21% - 35%)
and 39% (36% - 42%), respectively. The overall survival in ELBW was 34% (95%
CI: 31%
- 37%). In recent years, with good survival of VLBW neonates even in developing
countries, the focus has been shifted to ELBW neonates for improving the survival
of these vulnerable neonates. Data regarding improved survival among the micro-preemies
post-enhanced perinatal care from this part of the country is still lacking. So,
we have taken up this study to look at the mortality and morbidity outcomes of
ELBW neonates (especially micro preemies with birth weight <800 gm) in 2
time periods in a tertiary level 3 NICU in South India (pre-covid and post
covid periods). The reason for dividing into 2 separate time periods and
comparing outcomes is COVID-19 pandemic in 2020. With improvements in perinatal
and neonatal quality of services like Infrastructural changes including
acquiring new equipment, strict implementation of hygiene measures, improved staff-to-patient
ratio, and strict adherence to protocols survival of these micro-preemies might
have improved over the years. This data would help to address the factors
associated with the adverse outcomes, and good practices in NICUs associated
with the improved survival of ELBW babies and also help to counsel the parents
regarding the survival of micro preemies in the future. |