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Enrolled neonates will be provided routine supportive care as per existing neonatal intensive care unit (NICU)protocols. This will be carried out in the initial 6 months (0-180 days) of study commencement. This group will serve as control group (group A). During subsequent 6 months (181-360 days) of the study period, enrolled neonates fulfilling the inclusion criteria will be provided routine supportive care and the components of developmentally supportive care (DSC).
Enrolled neonates will be provided routine supportive care as per existing NICU protocols. This will be carried out in the initial 6 months (0-180 days) of study commencement. This group will serve as control group (group A). During subsequent 6 months (181-360 days) of the study period, enrolled neonates fulfilling the inclusion criteria will be provided routine supportive care and the components of developmentally supportive care (DSC). DSC components will be strictly emphasized on protected sleep, pain and stress assessment and management, activities of daily living (positioning, feeding and skin care), the healing environment. This group will be designated as group B. Both the groups will receive appropriate management for their morbidities as per existing NICU protocols. Both the groups will be followed up till 37 weeks of gestation where in their neurobehavioral assessment will be performed using Neurobehavioural assessment of preterm infants score.
In both the groups all the baseline data regarding antenatal factors will be recorded in a predesigned proforma such as age, gravid, Gestational age, Chorioamnionitis, Prenatal steroids, Multiple pregnancy, maternal comorbidities (preeclampsia, gestational diabetes mellitus), mode of delivery etc.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| developmentally supportive care | Other | enrolled neonates will be provided routine supportive care as per existing NICU protocols. This will be carried out in the initial 6 months (0-180 days) of study commencement. This group will serve as control group (group A). During subsequent 6 months (181-360 days) of the study period, enrolled neonates fulfilling the inclusion criteria will be provided routine supportive care and the components of developmentally supportive care(DSC). DSC components will be strictly emphasized on protected sleep, pain and stress assessment and management, activities of daily living (positioning, feeding and skin care), the healing environment. This group will be designated as group B |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| developmentally supportive care | Other | DSC components will be strictly emphasized on protected sleep, pain and stress assessment and management, activities of daily living (positioning, feeding and skin care), the healing environment |
| Measure | Description | Time Frame |
|---|---|---|
| Neurobehavioral outcome Of the Preterm Very low birth weight babies | Neurobehavioural outcome will be measured by NAPI at 37 weeks of corrected gestational age. | 18 months |
| Measure | Description | Time Frame |
|---|---|---|
| Time to achieve full feeds @150ml/kg | Time to achieve full feed @150 ml/kg/day will be measured in days. | 18 months |
| Length of hospital stay | will be measured in days |
| Measure | Description | Time Frame |
|---|---|---|
| Number of apneic episodes during hospital stay | will be measured as per standard definition of neonatal apnea and expressed as numbers. | 18 months |
| IVH Grade 2 or more | will be measured using bedside cranial sonogram and classified using Volpe's classification. |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| VIKRAM DATTA, MD,DNB | Contact | 91-1123344151 | 329 | drvikramdatta@gmail.com |
| ARVIND SAILI, MD,FRCPCH | Contact | 91-1123344151 | 335 | sailiarvind@gmail.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Lady Hardinge Medical College | Recruiting | New Delhi | National Capital Territory of Delhi | 110001 | India |
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| 18 months |
| 18 months |
| BPD | Presence or absence will be noted and mentioned as yes or no. | 18 months |
| NEC Stage 2 or more | Will be staged using Bells staging . | 18 months |
| ROP (any stage) | Will be graded using standard classification . | 18 months |
| Lady Hardinge Medical College,New Delhi | Recruiting | Delhi | India |
|