| CTRI Number |
CTRI/2018/09/015631 [Registered on: 06/09/2018] Trial Registered Prospectively |
| Last Modified On: |
05/09/2018 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Process of Care Changes |
| Study Design |
Cluster Randomized Trial |
|
Public Title of Study
|
STRESS IN MOTHERS RELATED TO ADMISSION OF THEIR BABIES IN NICU AND THE RESULT OF THEIR INVOLVEMENT IN THE CARE OF THEIR BABIES IN THE NICU. |
|
Scientific Title of Study
|
Stress in parents of low birth weight preterm babies and outcome of family integrated care |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Shreya Sinha |
| Designation |
UNDERGRADUATE STUDENT MBBS FINAL YEAR |
| Affiliation |
KASTURBA MEDICAL COLLEGE, MANIPAL |
| Address |
Room no-271
INDIRA HOSTEL
KMC CAMPUS
MADHAVNAGAR
MANIPAL KARNATAKA
Udupi
KARNATAKA
576104
India |
| Phone |
7026853784 |
| Fax |
|
| Email |
sinha.shreya1509@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DR LESLIE EDWARD LEWIS |
| Designation |
MD PEDIATRICS, PROFESSOR |
| Affiliation |
KASTURBA MEDICAL COLLEGE AND HOSPITAL, MANIPAL |
| Address |
DR. LESLIE EDWARD LEWIS
MD PEDIATRICS
DEPARTMENT OF PEDIATRICS
KASTURBA HOSPITAL
MANIPAL
Udupi
KARNATAKA
576104
India |
| Phone |
9449208476 |
| Fax |
|
| Email |
leslie.lewis1@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Shreya Sinha |
| Designation |
UNDERGRADUATE STUDENT MBBS FINAL YEAR |
| Affiliation |
KASTURBA MEDICAL COLLEGE, MANIPAL |
| Address |
ROOM NO-271
INDIRA HOSTEL
KMC CAMPUS
MADHAVNAGAR
MANIPAL KARNATAKA
Udupi
KARNATAKA
576104
India |
| Phone |
7026853784 |
| Fax |
|
| Email |
sinha.shreya1509@gmail.com |
|
|
Source of Monetary or Material Support
|
| Indian Council Of Medical Research(ICMR)
New Delhi
India |
|
|
Primary Sponsor
|
| Name |
Indian Council Of Medical Research |
| Address |
Indian Council Of Medical Research
V. Ramalingaswami Bhawan
P.O. BOX-4911
Ansari Nagar
New Delhi
110029
India |
| Type of Sponsor |
Research institution |
|
|
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 |
| SHREYA SINHA |
KASTURBA MEDICAL COLLEGE AND HOSPITAL MANIPAL |
Department Of Pediatrics
Kasturba Hospital
Manipal-576104
Udupi
KARNATAKA |
7026853784
sinha.shreya1509@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTEE KASTURBA MEDICAL COLLEGE MANIPAL |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: P05-P08||Disorders of newborn related to length of gestation and fetal growth, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Family Integrated Care |
Family Integrated Care is an approach to planning and delivery of health care that encourages greater parent involvement in their infants care. However, parents generally remain relegated to a supportive role in the NICU, and the majority of care for the infant is provided by NICU professionals.The Family Integrated Care (FICare) model is an extension of the principles of Family Centered Care. It is an actionable model by which parents are true partners in their infant’s care, even when in the NICU. This model was developed by a healthcare team that included parents who had previously been in the NICU (veteran parents). Integrating parents into the care team in Family Integrated Care goes well beyond merely allowing parents to be present and observe their infant’s care.
The goal of FICare is to facilitate a partnership and collaboration between parents and the NICU staff, to promote parent-infant interactions, and to build parent confidence. This is achieved by promoting information sharing between staff and parents and by parent participation in their infants care. Under the FICare model, parents are taught to be involved in all possible aspects of their infant’s care (e.g., feeding, diaper changes, bathing, providing oral medications), tracking growth and progress, decision-making, and taking part in medical rounds. Parental involvement in rounds supports parents in their partnership with the care team, helps them understand and participate in care decisions, and helps to strengthen relationships with the medical team. Parents are provided with support and education to provide care for their infant and grow into their roles as care providers for their infants. |
| Comparator Agent |
NOT APPLICABLE |
NOT APPLICABLE |
|
|
Inclusion Criteria
|
| Age From |
8.00 Month(s) |
| Age To |
9.00 Month(s) |
| Gender |
Both |
| Details |
1.MOTHERS AND THEIR PRETERM BABIES BORN BETWEEN 32 TO 37 WEEKS
2.MOTHERS WHO AGREE TO SPEND 6 HOURS PER DAY WIT THEIR INFANTS IN THE NICU.
3.MOTHERS WHO CAN READ AND WRITE ENGLISH WILL BE RECRUITED. |
|
| ExclusionCriteria |
| Details |
1.MOTHERS WITH TWINS OR HIGHER ORDER MULTIPLE BIRTHS
2. MOTHERS WHOSE INFANTS HAVE SEVERE CONGENITAL OR CHROMOSOMAL ANOMALIES. |
|
|
Method of Generating Random Sequence
|
Random Number Table |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Stress levels in mothers of preterm neonates before and after family integrated care using a parental stressor scale will be assessed and compared.
Outcome of family integrated care in terms of weight gain will be measured by using independent sample T-test. |
Stress levels in mothers of preterm neonates will be compared at the time of admission and during discharge of the babies in both the intervention and the control group. The hospital stay would vary according to neonatal condition. Outcome of family integrated care in terms of weight gain will be measured by using independent sample T-test. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Duration Of Hospital Stay
Weight Gain Of the Baby |
Duration of hospital stay and weight gain of the baby is compared in both the intervention and the control group. |
|
|
Target Sample Size
|
Total Sample Size="34"
Sample Size from India="34"
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)
|
08/09/2018 |
| 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
|
None yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
To compare the stress level in mothers of NICU preterm low birth weight babies using a parental stressor scale at the time of admission and during discharge of the baby and to know the result of FAMILY INTEGRATED CARE on the duration of hospital stay and growth(weight gain) in the new born. Preterm birth is a stressful event for parents and affects the parent-child relationship. As a result the infant’s development is affected physically, psychologically, and emotionally. Studies have shown that 13% of the mothers remain depressed till 27 months after birth and worry about child health among Neonatal intensive care unit(NICU) parents. Parent stress, anxiety, depression, and fatigue alter parenting behaviour and perception of parental competence, parent-infant interaction, and ultimately infant outcomes such as cognitive development, emotional regulation, and health. Many programs, such as kangaroo mother care, skin-to-skin care, and family-centred care have been developed to encourage greater parent involvement. However, most programs still adhere to the common premise that only NICU professionals with special skills can provide care for the infant, and parents are generally relegated to a supportive role. Studies have shown that Family Integrated Care(FIC) is feasible so this study will help to determine the outcome of FAMILY INTEGRATED CARE in terms of stress in mothers and the duration of stay of preterm babies. |