Very Low Birth Weight Baby
Conditions
Keywords
Developmentally Supportive Care
Brief summary
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).
Detailed description
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.
Interventions
OTHERdevelopmentally supportive care
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
Sponsors
Lady Hardinge Medical College
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
1 Days to 37 Weeks
Healthy volunteers
No
Inclusion criteria
* All stable preterm very low birth weight babies not on invasive mechanical ventilation * Hemodynamically stable * Parental consent
Exclusion criteria
* Babies with major congenital anomalies * Asphyxia (Apgar score \<3 at 5mins). * Acute bilirubin encephalopathy * Hypoglycemia at enrollment * Clinical Chorioamnionitis(fever \> 100.4 ◦ f , uterine fundal tenderness, maternal tachycardia (\>100/min), fetal tachycardia (\>160/min) and purulent or foul amniotic fluid ) * History of birth trauma
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Neurobehavioral outcome Of the Preterm Very low birth weight babies | 18 months | Neurobehavioural outcome will be measured by NAPI at 37 weeks of corrected gestational age. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Time to achieve full feeds @150ml/kg | 18 months | Time to achieve full feed @150 ml/kg/day will be measured in days. |
| Length of hospital stay | 18 months | will be measured in days |
Other
| Measure | Time frame | Description |
|---|---|---|
| NEC Stage 2 or more | 18 months | Will be staged using Bells staging . |
| Number of apneic episodes during hospital stay | 18 months | will be measured as per standard definition of neonatal apnea and expressed as numbers. |
| ROP (any stage) | 18 months | Will be graded using standard classification . |
| IVH Grade 2 or more | 18 months | will be measured using bedside cranial sonogram and classified using Volpe's classification. |
| BPD | 18 months | Presence or absence will be noted and mentioned as yes or no. |
Countries
India
Contacts
Primary ContactVIKRAM DATTA, MD,DNB
Backup ContactARVIND SAILI, MD,FRCPCH
Outcome results
None listed