| CTRI Number |
CTRI/2022/12/047815 [Registered on: 01/12/2022] Trial Registered Prospectively |
| Last Modified On: |
29/11/2022 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Process of Care Changes |
| Study Design |
Other |
|
Public Title of Study
|
Short-term and long-term outcomes of “Developmental and Supportive Care Interventions Bundle†in preterm neonates |
|
Scientific Title of Study
|
To assess the short-term and long-term outcomes of “Developmental and Supportive Care Interventions Bundle†in preterm neonates less than 32 weeks admitted in the Neonatal Intensive Care Unit, PGIMER, Chandigarh |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Urmila Pal |
| Designation |
Public Health Nursing Officer |
| Affiliation |
Post Graduate Institute of Medical Education and Research, Chandigarh |
| Address |
Office number 17, Neonatology Division, 3rd Floor, Block F, Nehru Hospital
PGIMER, Sector 12, Chandigarh, pin 160012
Chandigarh
CHANDIGARH
160012
India |
| Phone |
9814452228 |
| Fax |
|
| Email |
yadav.urmila593@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Prof Kanya mukhopadhyay |
| Designation |
Professor |
| Affiliation |
Post Graduate Institute of Medical Education and Research, Chandigarh |
| Address |
Office Number-4, Neonatology Division, 3rd floor, Block-F, Nehru Hospital
PGIMER, Sector 12, Chandigarh, pin 160012
Chandigarh
CHANDIGARH
160012
India |
| Phone |
9914208317 |
| Fax |
|
| Email |
kanyapgi@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Urmila |
| Designation |
Public Health Nursing Officer |
| Affiliation |
Post Graduate Institute of Medical Education and Research, Chandigarh |
| Address |
Office number 17, Neonatology Division, 3rd Floor, Block F, Nehru Hospital
PGIMER, Sector 12, Chandigarh, pin 160012
Chandigarh
CHANDIGARH
160012
India |
| Phone |
9814452228 |
| Fax |
|
| Email |
yadav.urmila593@gmail.com |
|
|
Source of Monetary or Material Support
|
| Post Graduate Institute of Medical Science and Research, chandigarh |
|
|
Primary Sponsor
|
| Name |
None |
| Address |
Not applicable |
| Type of Sponsor |
Other [nil] |
|
|
Details of Secondary Sponsor
|
|
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Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Urmila |
Post Graduate Institute of Medical Education and Research, Sector 12, Chandigarh, 160012 |
Neonatology Division, Department of Pediatrics, Nehru Hospital
Chandigarh
CHANDIGARH |
9814452228
yadav.urmila593@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Post Graduate Institute of Medical Education and Research, Chandigarh Institutional Ethics Committee |
Approved |
|
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Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: P073||Preterm [premature] newborn [other], |
|
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Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Development of “Developmental and Supportive Care Interventions Bundle†|
it involves set of interventions applied in NICU on preterm neonates with gestational age of 32 weeks by mothers and health care providers. It includes light control Protocol, noise control Protocol in NICU, TAC TIC: touch and caressing – tender in caring protocol. Gentle human touch, Kangaroo mother care, Therapeutic positioning and nesting, Pre feeding Oro motor Stimulation protocol, Range of motion exercises in preterm. |
| Comparator Agent |
Neurodevelopmental outcomes |
Primary outcomes
Secondary outcomes |
|
|
Inclusion Criteria
|
| Age From |
0.00 Month(s) |
| Age To |
8.00 Month(s) |
| Gender |
Both |
| Details |
1. Inborn pre-term neonates with gestational age of less than 32 weeks.
2. Inborn pre-term neonates admitted in NICU within 7 days of birth.
3. Parents of inborn pre-term neonates residing in or within 100km radius of Chandigarh and are willing to come for follow up for at least 2 years after discharge
|
|
| ExclusionCriteria |
| Details |
•Major congenital malformations.
•Syndromic neonates
•Proven intrauterine infection
•Sever perinatal asphyxia (APGAR score at 5 min is 0-3)
•Known case of visual and hearing abnormality diagnosed prior to enrolment.
•Pre-tern neonates whose mother has died or mentally impaired or not willing to participate.
|
|
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Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Composite adverse outcome which includes death and Neurodevelopmental impairment after discharge within first 2 years of life |
2 years |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Long term outcomes:
•weight at Corrected age of 1 year and 2 years
•Head Circumference and length at Corrected age of 1 year and 2 years
•Prevalence of seizure or epilepsy within first 2 years of life
•Preschool behavior outcomes
Short term outcomes:
•Reductions in Stress behavior signs during NICU stay
•Improvement in “Infant Positioning Assessment Tool score during NICU stay
•Weekly Weight gain, weight at discharge.
•Head Circumference and length at discharge.
•Transition time from oro-gastric tube feed to spoon feed and from spoon feed to direct breast feed
|
2 years |
|
|
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)
|
10/12/2022 |
| 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="24"
Months="11"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
|
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Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
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Brief Summary
|
Preterm neonates require highly specialized developmental care which involves adjusting the neonatal intensive care unit to reduce stress and improve optimal brain and behavioral development of the preterm neonate. A Prospective Longitudinal interventional study will be conducted in Neonatal Intensive Care Unit (NICU). Neonatal Intensive Care Unit is situated in the 3rd floor Nehru hospital, PGIMER, Chandigarh. Preterm neonates less than 32 weeks will be enrolled as Control and intervention group (150 each) after assessing for inclusion and exclusion criteria. a pilot study will be conducted to assess the feasibility. The study will not involve any alteration in investigations, treatment and routine care of any patient. Additional interventions are likely to improve the short term and long-term outcomes. All staffs of the NICU will be informed about the study and will be trained to provide the bundle care. The purpose of the study will be explained to the parents of preterm neonates and will be assured of confidentiality. A written informed consent will be obtained from the parents of preterm neonates and parents will be given full authority to take decision for their participation and they could withdraw from the study at any point without any adverse effect on their subsequent care. Mother will be involved in day-to-day care of the stable neonate (nappy changes, cleaning etc.) Pre-intervention data will be collected in control group before the implementation of intervention bundle. For Implementation of “Developmental and Supportive Care Interventions Bundle†regular and frequent sessions of teaching, demonstration and training of health care providers and mothers of preterm-neonates will be conducted by researcher till overall coverage. post discharge follow-ups will be conducted on set time periods. At the time of discharge pre-discharge clinical assessment will be done which include mode of feeding at discharge, type of feed, weight at discharge, head circumference, length and short version hammersmith neonatal neurodevelopmental examination. Anthropometric assessment will be performed at the age of 3,6,9,12,18 and 24 months. At corrected age of 12±2 months and 24±3 months, babies will be tested by DASII scale and hammersmith infant neurodevelopmental examination. At chronological age of 2 years behavior will be assessed by preschool behavioural checklist |