Health Condition 1: D599- Acquired hemolytic anemia, unspecified
Conditions
Interventions
Intervention1: Group A: Intervention Group will receive
Folic acid (100 g/day)along with Vitamin B12 (2.5 g/day) orally
: Supplementation will be initiated after the establishment of full enteral f
Sponsors
PGIMER Chandigarh
Eligibility
Inclusion criteria
Inclusion criteria: All of the following: 1. Neonates born to Rh isoimmunized mothers (ICT equal to or more than 1:8) 2. Direct Coombs Test (DCT) positive or history of intrauterine transfusion 3. Parent/guardian provides written informed consent
Exclusion criteria
Exclusion criteria: Any of the following: 1. Parents/guardians unwilling to provide consent 2. Major congenital anomalies or chromosomal disorders Congenital anomalies are structural or functional anomalies that occur during intrauterine life and can be identified prenatally or at birth, or may only be detected later in infancy. Congenital anomalies will be classified as major or minor according to the WHO birth defects surveillance manual. A major anomaly refers to structural alterations that can have notable medical, social, or cosmetic implications for the individual affected, and generally necessitate medical intervention. Examples include anencephaly, encephalocele, congenital hydrocephalus, malformations of cardiac chambers and connections, abnormalities of the great arteries, congenital malformations of the nose, larynx, trachea, bronchus, and lung, as well as cleft lip and palate.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Mean hemoglbin (mg/dL) in group receiving folic acid and vitamin B12 supplementation compared to the group not receiving, measured using an automated hematology analyzer.Timepoint: 12 weeks postnatal age | — |
Secondary
| Measure | Time frame |
|---|---|
| Incidence of anemia (defined as hemoglobin less than 11 g/dL) in intervention and control group each. Receipt of PRBC transfusion at any time during the first 12 weeks of life in intervention and control group each. We will follow thresholds provided as per NNF guidelines for transfusion in these neonates. Incidence of iron overload at 12 weeks (defined as serum ferritin more than 300 g/L) in intervention and control group each. Levels of vitamin B12 and folate at 12 weeks of life in intervention and control group each.Timepoint: 12 weeks | — |
Countries
India
Contacts
Public ContactJogender Kumar
Postgraduate Institute of Medical Education and Research (PGIMER) Chandigarh
Outcome results
None listed