Very Low Birth Weight Baby Clinical Trial
Official title:
Evaluation of the Effect of Application of Developmentally Supportive Care on Neurobehavioral Outcome of Preterm Very Low Birth Weight Neonates
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.
;
Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Supportive Care
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Recruiting |
NCT03896893 -
Neonatal Bacterial Colonization Study
|
N/A | |
| Completed |
NCT01350765 -
Naushero Feroze Neonatal Survival Project
|
N/A | |
| Completed |
NCT03403530 -
Efficacy of IgM Rich Immunoglobulin With Antibiotics for Bacterial Sepsis in Very Low Birth Weight Preterm Neonates
|
Phase 4 | |
| Completed |
NCT01360528 -
Serum Folic Acid Levels in Preterm Infants
|
N/A | |
| Completed |
NCT06379178 -
Effect of Oral Colostrum Applications Every 2 Hours and 4 Hours In Order to Achieve Trophic Feeding in Preterm Infants
|
N/A | |
| Completed |
NCT01335490 -
Intervening to Improve Infant Health in Ghana
|
N/A | |
| Completed |
NCT03214822 -
Human-derived Human Milk Fortifiers (H2MF), Gut Microbiota and Oxidative Stress in Premature Infants
|
N/A | |
| Completed |
NCT01220687 -
Inhaled Nitric Oxide (iNO) as an Adjunct to Neonatal Resuscitation
|
N/A |