A clinical trial to evaluate the effects of iron therapy in term newborns.

A Randomised control study to evaluate the effects of iron therapy on serum ferritin and hemoglobin in term newborns at six months of age

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2016/09/007242

Enrollment

200

Registered

2016-09-06

Start date

Unknown

Completion date

Unknown

Last updated

2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Intervention1: ORAL IRON SUPPLEMENTATION IN NEONATES OF ANAEMIC MOTHERS: Ferrous ascorbate equivalent to 10 mg of elemental iron/ml with dose of 2 mg/kg/day in a single dose per day for 6 months will

Eligibility

Inclusion criteria

Inclusion criteria: All mothers admitted in labour room or planned for cesarean section will be screened for eligibility. 1)pregnant women are eligible if they meet the following criteria;non-smoking,no known hemolytic disease(sickle cell disease/Hb E disease),no treatment with with any of the drugs like anticonvulsants,antidepressants,thyroid hormone,chemotherapy or cortisone. 2)normal pregnancy(no eclampsia,no diabetes,no prolonged rupture of membranes or signs of infection) 3)singleton;term pregnancy (gestational age 37 weeks to 41 weeks 6days )in labour ward or cesarean section theatre. 4)The neonate should live within 100 km from the hospital (dibrugarh district) and parents should be willing to give consent and to come for follow up till 6 months of age. 5)Delivery should occur in week days between 8am to 8pm.

Exclusion criteria

Exclusion criteria: 1)Rh incompatibility,congenital malformations or syndromes, 2)Parents not willing to participate and not willing to return for follow up 3)Term neonates admitted in NICU,delivery from 8pm to 8am,delivery on holidays.

Design outcomes

Primary

Measure	Time frame
Infants haemoglobin and iron store status (S.ferritin) at 6months of age.Timepoint: Infants haemoglobin and iron store status (S.ferritin) at 6months of age.	—

Secondary

Measure	Time frame
Neurodevelopment at 6 months of age and 9 months of age.Timepoint: Neurodevelopment at 6 months of age and 9 months of age.	—

Countries

India

Contacts

Public ContactDrsutharsonR

Assam medical college

rbora_amc@yahoo.co.in9435394313

Outcome results