| CTRI Number |
CTRI/2025/08/093626 [Registered on: 25/08/2025] Trial Registered Prospectively |
| Last Modified On: |
25/08/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Process of Care Changes |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Testing a new method of caring for premature babies to see if it helps them get better faster recovery compared to the usual care they receive |
|
Scientific Title of Study
|
Evaluation of comparative efficacy of newly developed clinical pathway for care of preterm neonates as against the existing newborn nursing care pathway on neonatal outcome |
| Trial Acronym |
nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Shalini Lokhande |
| Designation |
Assistant Professor |
| Affiliation |
Datta Meghe Institute of Higher Education and Research |
| Address |
Dept of Child Heaith Nursing, Ground Floor, SRMMCON Building, Sawangi Meghe
Wardha
MAHARASHTRA
442001
India |
| Phone |
9765304976 |
| Fax |
|
| Email |
shalini_lokhande@rediffmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Amar Taksande |
| Designation |
Professor and Head |
| Affiliation |
Datta Meghe Institute of Higher Education and Research |
| Address |
Dept of Pediatrics, 2nd Floor, AVBRH Building, Sawangi Meghe
Wardha
MAHARASHTRA
442001
India |
| Phone |
9822369233 |
| Fax |
|
| Email |
amar.taksande@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Amar Taksande |
| Designation |
Professor and Head |
| Affiliation |
Datta Meghe Institute of Higher Education and Research |
| Address |
Dept of Pediatrics, 2nd Floor, AVBRH Building, Sawangi Meghe
Wardha
MAHARASHTRA
442001
India |
| Phone |
9822369233 |
| Fax |
|
| Email |
amar.taksande@gmail.com |
|
|
Source of Monetary or Material Support
|
| Datta Meghe Institute of Higher Education and Research, Sawangi Meghe Wardha India 442001 |
|
|
Primary Sponsor
|
| Name |
Datta Meghe Institute of Higher Education and Research |
| Address |
Sawangi Meghe Wardha India 442001 |
| 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 Amar Taksande |
Acharya Vinoba Bhave Rural Hospital |
Dept of Pediatrics, 2nd floor, AVBRH Building, Sawangi Meghe
Wardha
MAHARASHTRA |
9822369233
amar.taksande@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, Datta Meghe Institute of Higher Education and Research, Wardha |
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 |
Newly developed Clinical pathway for care of preterm neonates |
New care guidelines will be followed for the preterm neonates for a period of 7 days. |
| Comparator Agent |
Standard care in NICU for preterm neonates |
Standard care will be provided to preterm neonates in NICU for 7 days. |
|
|
Inclusion Criteria
|
| Age From |
1.00 Day(s) |
| Age To |
30.00 Day(s) |
| Gender |
Both |
| Details |
1.Parents’ consent for willingness to include their preterm baby in study
2.Preterm neonate from 28 and 37 weeks of gestational age
3.Appropriate for their gestational age. |
|
| ExclusionCriteria |
| Details |
1. Child with various complications including bronchopulmonary dysplasia, interventricular hemorrhage, periventricular leukomalacia, necrotizing enterocolitis, and congenital anomalies |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Reduced Morbidity and length of stay in NICU |
Assessment will be done at 1 week. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="200"
Sample Size from India="200"
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
|
Phase 3/ Phase 4 |
|
Date of First Enrollment (India)
|
01/10/2025 |
| 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="2"
Months="0"
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 - NO
|
|
Brief Summary
|
Preterm birth is a significant public health issue across the world because of associated neonatal (first 28 days of life) mortality and short-term and long-term morbidity and disability in later life. According to WHO, every year about 15 million babies are born prematurely around the world and that is more than 1 in 10 of all babies born globally. Almost 1 million children die each year because of complications of preterm birth (2013). Across 184 countries, the rate of preterm birth ranges from 5% to 18% of babies born. In India, out of 27 million babies born every year (2010 data), 3.5 million babies born are premature as per the estimates. Clinical Pathway (CP) is a term used to describe interdisciplinary plans of best care for designated groups of clients with a specific disease. These plans help with coordination and the provision of high-quality care. It also follows a systematic therapy plan with predetermined results. Clinical Pathway can also be referred to by the terms Anticipatory recovery paths (ARPs), Integrated Care routes, Multidisciplinary pathways of care (MPCs), Care Maps, Collaborative Care paths, and Critical Pathway The impact of specific developmental care practices on preterm infants has been researched extensively. Moreover, the dissemination of knowledge about developmental care has facilitated broader care that combines different kinds of developmental care practices in different NICUs. However, little is known about how variation in nursing care affects infant’s outcomes So the aim of this study is The study aims to evaluate the effectiveness of clinical pathway for care of preterm to improve the preterm outcome.
The study aims to evaluate the effectiveness of clinical pathway for care of preterm to improve the preterm outcome. |