Health Condition 1: P073- Preterm [premature] newborn [other]
Conditions
Interventions
Intervention1: High dose Vitamin B12: Babies will receive high dose injection vitamin B12.
Route: Intramuscular injection
Dose: 25 mcg
Frequency: starting from day 7 of life, repeated every 7 days du
Sponsors
Dr Nishant Banait
Dr Mansi Madan
Eligibility
Inclusion criteria
Inclusion criteria: Preterm neonates between 28+0-33+6 weeks of gestation admitted to the NICU at AIIMS Nagpur.
Exclusion criteria
Exclusion criteria: 1. Out-born preterm neonates between 28+0-33+6 weeks of gestation admitted after 24 hours of birth to the NICU at AIIMS Nagpur. 2. Parents and guardians unwilling to provide consent for the study. 3. Major congenital malformation. 4. Hemolytic disease. 5. Twin to twin transfusion syndrome. 6. Major hemorrhage (including IVH grade III/IV, major GI bleed, UVC bleed, history of peripartum hemorrhage).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in hemoglobin (Hb) levels from baseline to 4 weeks of age.Timepoint: Baseline Hb will be evaluated with CBC within 24 hours of birth and repeated every 7 days before administration of next dose of intramuscular injection of vitamin B12 till discharge. Change in Hb levels will be assessed. | — |
Secondary
| Measure | Time frame |
|---|---|
| Reduction in the incidence of anemia.Timepoint: Baseline Complete blood count will be taken within 24 hours of birth and repeated every 7 days before administration of next dose of intramuscular injection of vitamin B12 till discharge. Anemia will be diagnosed based on available reference charts.;Change in RBC indices (MCV, RBC count, reticulocyte count).Timepoint: Baseline Complete blood count will be taken within 24 hours of birth and repeated every 7 days before administration of next dose of intramuscular injection of vitamin B12 till discharge. Reference values will be compared with charts as mentioned in Annexures;Change in serum vitamin B12 levels.Timepoint: Baseline value of serum Vitamin B12 will be taken within 24 hours of life and then repeated every 14 days, before administration of dose of intramuscular injection of vitamin B12 till discharge.;Incidence of anemia requiring blood transfusion.Timepoint: Baseline Complete blood count will be taken within 24 hours of birth and repeated every 7 days before administration of next dose of intramuscular injection of vitamin B12 till discharge. Blood transfusion cut- off will be decided as per unit protocol as mentioned in annexure.;Association between maternal serum B12 and neonatal serum B12 levels.Timepoint: Maternal serum Vitamin B12 levels will be assessed once at baseline, i.e. within 24 hours of delivery.;Change in growth parameters on receiving vitamin B12 therapyTimepoint: Anthropometry recordings of length, weight and head circumference will be done at admission then once every week till discharge. | — |
Countries
India
Contacts
Public ContactDr Mansi Madan
All India Institute of Medical Sciences, Nagpur
Outcome results
None listed