| CTRI Number |
CTRI/2025/11/097516 [Registered on: 17/11/2025] Trial Registered Prospectively |
| Last Modified On: |
17/11/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Process of Care Changes |
| Study Design |
Non-randomized, Active Controlled Trial |
|
Public Title of Study
|
Impact of Involving Families in Newborn Care on Infection Rates and Hospital Stay in a Neonatal Intensive Care Unit |
|
Scientific Title of Study
|
Impact of Family-Centered Care on the Incidence of Neonatal Sepsis and
Duration of Hospital Stay at a Tertiary Care Neonatal Intensive Care Unit: A Quasi-experimental Study |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Mohd Shahnazar |
| Designation |
Post Diploma DNB Student |
| Affiliation |
Maharaja Agrasen Medical College Agroha Hisar |
| Address |
Room NO. 91 Department of Paediatrics MAMC Agroha Hisar
Department of Paediatrics MAMC Agroha Hisar
Hisar
HARYANA
125047
India |
| Phone |
07500473911 |
| Fax |
|
| Email |
dr.shanansari786@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Rakesh Kumar |
| Designation |
Professor |
| Affiliation |
Maharaja Agrasen Medical College Agroha hisar |
| Address |
Room NO.90 Paediatric OPD A BLOCK MAMC Agroha Hisar
Hisar
HARYANA
125047
India |
| Phone |
8930200825 |
| Fax |
|
| Email |
paediatrics@mamc.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Mohd Shahnazar |
| Designation |
Post Diploma DNB Student |
| Affiliation |
Maharaja Agrasen Medical College Agroha hisar |
| Address |
ROOM NO 91 Department of Paediatrics MAMC Agroha Hisar
Department of Paediatrics MAMC Agroha Hisar
Hisar
HARYANA
125047
India |
| Phone |
07500473911 |
| Fax |
|
| Email |
dr.shanansari786@gmail.com |
|
|
Source of Monetary or Material Support
|
| Maharaja Agrasen Medical College Agroha Hisar Haryana India Pin 125047 |
|
|
Primary Sponsor
|
| Name |
Maharaja Agrasen Medical College Agroha Hisar |
| Address |
Maharaja Agrasen Medical College Agroha Hisar Haryana India Pin 125047 |
| 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 Karnika Agrawal |
Maharaja Agrasen Medical College |
ROOM 91,Department of Paediatrics Maharaja Agrasen Medical College Agroha
NH-10 VPO Agroha, District- Hisar
Hisar
HARYANA |
8059784475
karnika.pediatrics@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee For Human Research MAMC Agroha |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: P00-P96||Certain conditions originating in the perinatal period, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Family-Centered Care |
In Phase 2 of study Family centered care will be introduced in NICU. Parental Presence and Participation in newborn care in neonatal ICU.
Parent Education and Training
Collaborative Care Planning will lead to
Infection Prevention Through Family Engagement. |
| Comparator Agent |
Standard Newborn Care |
In phase 1 of the study standard Newborn care will be provided and baseline data will be collected before initiating Family centered care in NICU. |
|
|
Inclusion Criteria
|
| Age From |
1.00 Day(s) |
| Age To |
30.00 Day(s) |
| Gender |
Both |
| Details |
Gestational age greater than or equal to 28 weeks
Admitted to NICU within 72 hour of birth
At least one caretaker is available and willing to participate in the study. |
|
| ExclusionCriteria |
| Details |
Neonates transferred to or from other facilities during care
Parents unwilling to participate
Neonates requiring immediate surgical interventions. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
Incidence of Neonatal Sepsis
|
1 weeks 10 days 2 weeks and till discharge |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Nil |
Nil |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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)
|
01/12/2025 |
| 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="0"
Months="6"
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
|
This quasi-experimental study will be conducted in the NICU of a tertiary healthcare centre over six months, divided into two phases. The study follows a non-randomized, pre-post intervention design. During the first three months (pre-intervention phase), baseline data on neonatal sepsis incidence and hospital stay duration will be collected.Subsequently, Family-Centred Care(FCC) will be introduced in the NICU. Parents will be educated and trained in essential newborn care practices.Over the next three months (post-intervention phase), data will be collected from neonates admitted during this period, now receiving care under the FCC model The incidence of neonatal sepsis and the duration of hospital stay will be compared between the pre- and post-intervention groups to evaluate the impact of FCC. |