| CTRI Number |
CTRI/2025/05/087251 [Registered on: 21/05/2025] Trial Registered Prospectively |
| Last Modified On: |
21/05/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Preventive |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
To assess the benefits of early iron supplementation at 2 weeks post gestational age in preterm very low birth weight infants.
|
|
Scientific Title of Study
|
Single blinded parallel group interventional randomised control trial to assess the benefits of early iron supplementation at 2 weeks post gestational age in preterm very low birth weight infants.
|
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Manasa Rao |
| Designation |
Post graduate in Pediatrics |
| Affiliation |
Karnataka Institute of Medical Sciences, Hubli |
| Address |
004 Westblock, Tigris Apartments, Planters lane, Bunts hostel, Mangalore
Post graduate, Department of Paediatrics, Karnataka Institute of Medical Sciences and Reseach Centre, KMCRI, Vidyanagar, Hubballi
Dharwad
KARNATAKA
575003
India |
| Phone |
9113272870 |
| Fax |
|
| Email |
manasarao1999@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr S R Fattepur |
| Designation |
Associate Professor |
| Affiliation |
Karnataka Institute of Medical Sciences and Research Centre, KMCRI, Hubli |
| Address |
DEPT OF PEDIATRICS KARNATAKA INSTITUTE OF MEDICAL SCIENCES AND RESEARCH CENTRE, HUBBALLI
Dharwad
KARNATAKA
580022
India |
| Phone |
9686034356 |
| Fax |
|
| Email |
sshayan26@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr S R Fattepur |
| Designation |
Associate Professor |
| Affiliation |
Karnataka Institute of Medical Sciences and Research Centre, KMCRI, Hubli |
| Address |
DEPT OF PEDIATRICS KARNATAKA INSTITUTE OF MEDICAL SCIENCES AND RESEARCH CENTRE, VIDYA NAGAR HUBBALLI
Dharwad
KARNATAKA
580022
India |
| Phone |
9686034356 |
| Fax |
|
| Email |
sshayan26@gmail.com |
|
|
Source of Monetary or Material Support
|
| Karnataka Institute of Medical Science and Research Centre, Vidya Nagar, Hubballi |
|
|
Primary Sponsor
|
| Name |
NA |
| Address |
NA |
| Type of Sponsor |
Other [Personal] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Manasa Rao |
Karnataka Institute of Medical Science and Research Centre |
Karnataka Institute of Medical Science and Research Centre, KMCRI, P. B Road, Vidyanagar, Hubbali, Karnataka 580022
Dharwad
KARNATAKA |
9113272870
manasarao1999@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Karnataka Institute of Medical Sciences, Hubballi Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: P07||Disorders of newborn related to short gestation and low birth weight, not elsewhere classified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
MILTOFER DROPS |
3ml/kg/day iron drops will be given at 2 weeks in early group and at 4 weeks in late intervention group |
| Intervention |
MILTOFER Iron drops |
3ml/kg/day iron drops will be given at 2 weeks in early group and at 4 weeks in late intervention group |
|
|
Inclusion Criteria
|
| Age From |
14.00 Day(s) |
| Age To |
56.00 Day(s) |
| Gender |
Both |
| Details |
preterm less than 37 weeks, less than 1500gm, who have reached 100ml/kg/day by 2 weeks of age |
|
| ExclusionCriteria |
| Details |
o Babies with major congenital anomalies especially GI tract anomalies o multiple gestation o Rh incompatibility
o ABO haemolytic diseases requiring exchange transfusion o neonates undergoing surgery o intraventricular haemorrhage o antepartum haemorrhage will be excluded. o Parents who refuse follow up
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Reticulocyte Hemoglobin Equivalent will be measured at 8 weeks of life of the neonate |
At 8 weeks of life of the neonate |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Incidence of neonatal morbidities, haemoglobin level, anthropometric parameters and blood
transfusion after inclusion in the study and at the end of 2 weeks. |
2 weeks |
|
|
Target Sample Size
|
Total Sample Size="72"
Sample Size from India="72"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
01/06/2025 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="1"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
The effects of iron deficiency are extensive and involve multiple organ systems. Poor physical growth, gastrointestinal disturbances, thyroid dysfunction, altered immunity and temperature instability has been attributed to iron deficiency in very low birth weight (VLBW, birth weight <1500g) infants. Anaemia, a late sign of iron deficiency, signals significant depletion of iron stores, causing significant structural and functional impairments in neurodevelopment as well as long-term cognitive abnormalities, seemingly irreversible even with iron supplementation. Maternal-fetal iron transport predominantly takes place in the third trimester, making premature birth a potential factor leading to significant iron deficiency during a crucial phase of neurodevelopment.Early iron (EI) supplementation holds the potential to enhance iron stores and avert depletion. The optimal timing for commencing prophylactic enteral iron supplementation in preterm very low birth weight (VLBW) infants is debated internationally by various bodies, with recommendations spanning from 2 to 8 weeks, and the resolution of this matter is yet to be achieved.Most international bodies also recommend delayed initiation of prophylactic enteral iron supplementation considering the potentially increased risk of free radical mediated morbidities in preterm neonates. However, in earlier studies there was no evidence of adverse effects after early enteral iron supplementation. Moreover previous studies using serum ferritin as an outcome measure have yielded conflicting results on the benefits of early supplementation of iron. SF, while a reliable biomarker for iron, is also an acute phase protein elevated during systemic inflammation, potentially masking the presence of iron deficiency.In such situations, the Reticulocyte Haemoglobin Equivalent (RET-He) emerges as a more valuable and an early marker unaffected by inflammation and infection. RET-He value reflects the iron available for production of red blood cells which recently released from bone marrow in the previous 3–4 days. This lets us detect changes in iron status far earlier unlike traditional haematological parameters like HGB, MCV, MCH, or HYPO-He, which may indicate iron deficiencies relatively late. The clinical utility of RET-He as an early marker with cut off <29pg for iron deficiency anaemia has been established, with high sensitivity, specificity, and negative predictive values,making ita valuable parameter in advanced haematological analysis. Hence, a study is essential to examine the benefits of early iron supplementation (at 2 weeks postnatal age) in preterm very low birth weight (VLBW) infants, as compared with late supplementation at 4 weeks, with RET-He serving as the primary outcome measure. |