| CTRI Number |
CTRI/2022/03/040781 [Registered on: 03/03/2022] Trial Registered Prospectively |
| Last Modified On: |
16/02/2022 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Preventive
Other (Specify) [Nursing Intervention ] |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Effect of Nurse Led Developmental Intervention Packages on Neurodevelopmental Outcome of Preterm babies in AIIMS, Jodhpur. |
|
Scientific Title of Study
|
A Randomized Controlled Trial to Asess the Effectiveness of Nurse Led Developmental Intervention Packages on Neurodevelopmental Outcome of Preterm babies in AIIMS, Jodhpur. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
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Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
RAGHU VA |
| Designation |
Nursing Tutor |
| Affiliation |
All India Institute of Medical Sciences, Jodhpur |
| Address |
College of Nursing
All India Institute of Medical Sciences, Jodhpur
Jodhpur
RAJASTHAN
342005
India |
| Phone |
8447007616 |
| Fax |
|
| Email |
raghuva84@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Manju Vatsa |
| Designation |
Former Principal |
| Affiliation |
All India Institute of Medical Sciences, Delhi |
| Address |
College of Nursing
All India Institute of Medical Sciences, New Delhi
East
DELHI
110051
India |
| Phone |
09810131175 |
| Fax |
|
| Email |
mvatsa2001@yahoo.co.in |
|
Details of Contact Person
Public Query
|
| Name |
RAGHU VA |
| Designation |
Nursing Tutor |
| Affiliation |
All India Institute of Medical Sciences, Jodhpur |
| Address |
College of Nursing
AIIMS, Jodhpur
Jodhpur
RAJASTHAN
342005
India |
| Phone |
8447007616 |
| Fax |
|
| Email |
raghuva84@gmail.com |
|
|
Source of Monetary or Material Support
|
| All India Institute of Medical Sciences, NICU, Department of Neonatology, Jodhpur |
|
|
Primary Sponsor
|
| Name |
Raghu V A |
| Address |
College of Nursing
AIIMS, Jodhpur |
| Type of Sponsor |
Other [self ] |
|
|
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 |
| Raghu V A |
All India Institute of Medical sciences, Jodhpur |
All India Institute of Medical Science, Neonatal Intensive Care Unit, Department of Neonatology, Third floor, OPD Building, Jodhpur
Rajasthan
Jodhpur
RAJASTHAN |
8447007616
raghuva84@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Commitee (Clinial trial) , AIIMS, Jodhpur |
Approved |
|
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Regulatory Clearance Status from DCGI
|
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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 |
| Comparator Agent |
The control group will receive only Neurodevelopmental supportive care during Hospitalization. At home, caregivers follow discharge instructions. |
The Neurodevelopmental supportive care Includes
1. Nesting
2. Swaddling
3. Containment/ Facilitates Tucking
4. Non-Nutritive Sucking
5. Prevention of Pain by using Dextrose/ Sucrose, NNS, and Facilitated Tucking
6. Family-Centered care
7. Kangaroo Mother care
8. Breast Feeding/ Feeding With Breast Milk
9. Massage therapy with Coconut oil
10. Environmental Modification: Maximum reduction of Noise ( NICU Background Noise Level between 60-70 dB) and Avoiding exposure to bright light. |
| Intervention |
The intervention group will receive the Nurse Led Developmental intervention package. It includes Neurodevelopmental supportive care and Multisensory stimulation during hospitalization.
The neurodevelopmental supportive care is provided from the day of recruitment till the discharge from the hospital.
The Multi sensory stimulation is provided from 31 weeks of gestation till the discharge from the hospital.
An Age Appropriate multisensory stimulation will be given by caregivers at home after discharge from Hospital till the 6 months of corrected age |
Neurodevelopmental Supportive care is provided to babies born less than 36 weeks of gestational age from the 5th day of admission in NICU. The Neurodevelopmental supportive care Includes
1. Nesting
2. Swaddling
3. Containment/ Facilitates Tucking
4. Non-Nutritive SUcking
5. Prevention of Pain by using Dextrose/ Sucrose, NNS, and Facilitated Tucking
6. Family-Centered care
7. Kangaroo Mother care
8. Breast Feeding/ Feeding With Breast Milk
9. Massage therapy with Coconut oil
10. Environmental Modification: Maximum reduction of Noise ( NICU Background Noise Level between 60-70 dB) and Avoiding exposure to bright light.
Multisensory stimulation is provided to preterm neonates from 31st weeks of Gestational age. The multisensory stimulation includes auditory, tactile, visual, vestibule kinaesthetic, gustatory stimulation, massage therapy, and passive exercise.
Auditory stimulation: Recorded Mother voice and Calming music (Veena, Tabala, recorded lullaby (30–40 dB)) is put near to the baby for 5 min using a miniature speaker. Auditory stimulation is given for 5 minutes duration and 2 times a day.
Tactile stimulation: It is given in the form of mother therapeutic touch. The tactile stimulation is done with two or three fingers with a gentle pressure three times in one direction and in the opposite direction on the temporal, frontal, periorbital, and nasal regions of the face. The mother is asked to touch whole body parts during a diaper change. Tactile stimulation is given three times a day.
Vestibular kinaesthetic stimulation: It is provided by gently rocking the baby and slowly swinging the baby horizontally and vertically. The mother is also asked to pull the baby vertically upward from the supine position by holding the shoulder and neck. This procedure is done five minutes two times a day.
Visual stimulation: Vision sense is developed at last in neonates. To provide visual stimulation dim light is provided and avoid exposure to bright light. Initially black and white color with bold pattern and strong contrast is kept 8-12 inches from the baby for 15 to 20 minutes, two times a day for visual stimulation.
Massage therapy: Coconut oil is used for massaging the baby. Massage is done using two fingers kept flat on the body and providing long gentle strokes for 5-10 minutes duration once a day. leathery touch is avoided.
Passive exercise: Passive exercise is provided once a day during hospitalization.
Age-appropriate multisensory stimulation will be administered at the home by the caregivers after discharge from the hospital. Age-appropriate stimulation is provided till six months of corrected age.
Before starting the study, the training will be provided to Nursing Officers and Mothers of Preterm babies.
|
|
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Inclusion Criteria
|
| Age From |
6.00 Month(s) |
| Age To |
9.00 Month(s) |
| Gender |
Both |
| Details |
1. Babies born Less than 36 weeks of GA.
2. Babies who are admitted to the AIIMS hospital Jodhpur
3. Preterm baby admitted in NICU for more than 5 days.
|
|
| ExclusionCriteria |
| Details |
1. Preterm babies with congenital anomalies and who require surgical treatment at birth.
2. TORCH Infection
3. Inborn Error of Metabolism |
|
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Method of Generating Random Sequence
|
Computer generated randomization |
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Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Open Label |
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Primary Outcome
|
| Outcome |
TimePoints |
| The outcome variables are cognitive, motor development, language development and social –emotional development of preterm babies at 9-months corrected age as it is assessed by Bayley Scales of Infant and Toddler Development Third Edition. |
3 Months 6 Months and 9 Months corrected age |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. Factors associated with Neurodevelopmental outcome of preterm babies
2. Parental satisfaction with Neurodevelopmental supportive care.
3. Knowledge Attitude and Skill of Nursing officer before and after the training on neurodevelopmental supportive care.
4. Effect of the different risk factors of the preterm baby on neurodevelopmental outcome.
|
9 Months of Corrected age. |
|
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Target Sample Size
|
Total Sample Size="220"
Sample Size from India="220"
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)
|
02/05/2022 |
| 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="3"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
Nil |
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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
|
This is a Randomized, open-label, parallel-group single-center trial to compare the efficacy of Nurse-Led developmental intervention packages on the neurodevelopmental outcome of preterm babies in AIIMS, Jodhpur at 9 months of corrected age among 220 preterm babies born less than 36 weeks of gestational age admitted in NICU. The primary outcome of the study is cognitive, motor, language, and socioemotional development of preterm babies as assessed by Bayley Infant and Toddler developmental scale, Edition III at 3 months, 6 months and 9 months follow up. |