| CTRI Number |
CTRI/2024/05/066651 [Registered on: 02/05/2024] Trial Registered Prospectively |
| Last Modified On: |
01/05/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Biological
Diagnostic
Preventive
Screening |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparison of serum ferritin level guided and standard practice of oral iron supplementation in very preterm neonates |
|
Scientific Title of Study
|
Serum Ferritin level guided vs Standard practice of oral iron supplementation in very preterm neonates hospitalized in tertiary care NICU - A Prospective randomised control superiority trial |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Sunil Hanasi |
| Designation |
DrNB resident |
| Affiliation |
Rainbow Childrens Hospital and Birthright . Banjara hills Road number 2 . Hyderabad |
| Address |
Department of Neonatology
Second floor
Rainbow Childrens Hospital and Birthright .Road number 2 , Banjara hills Hyderabad Telangana 500034
Department of Neonatology
Second floor
Rainbow Childrens Hospital and Birthright .Road number 2 , Banjara hills Hyderabad
Hyderabad
TELANGANA
500034
India |
| Phone |
9535573835 |
| Fax |
|
| Email |
sunilhanasi@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Nalinikanta Panigrahy |
| Designation |
Senior Consultant Neonatologist |
| Affiliation |
Rainbow Childrens Hospital and Birthright . Banjara hills Road number 2 . Hyderabad |
| Address |
Department of Neonatology Second floor Rainbow Childrens Hospital and Birthright .Road number 2 ,Banjara hills Hyderabad Telangana 500034
Department of Neonatology Second floor Rainbow Childrens Hospital and Birthright Road number 2 , Banjara hills Hyderabad Telangana 500034
Hyderabad
TELANGANA
500034
India |
| Phone |
9535573835 |
| Fax |
|
| Email |
nalini199@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Sunil Hanasi |
| Designation |
DrNB resident |
| Affiliation |
Rainbow Childrens Hospital and Birthright . Banjara hills Road number 2 . Hyderabad |
| Address |
Department of Neonatology Second floor Rainbow Childrens Hospital and Birthright .Road number 2 , Banjara hills Hyderabad Telangana 500034
Department of Neonatology Second floor Rainbow Childrens Hospital and Birthright Road number 2 , Banjara hills Hyderabad Telangana 500034
Hyderabad
TELANGANA
500034
India |
| Phone |
9535573835 |
| Fax |
|
| Email |
sunilhanasi@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Neonatology Second floor Rainbow Childrens Hospital and Birthright Road number 2 Banjara hills Hyderabad |
| Rasearch Grant |
|
|
Primary Sponsor
|
| Name |
Rainbow Children s Hospital and Birthright . |
| Address |
Banjara hills Road number 2 . Hyderabad
500034 |
| Type of Sponsor |
Research institution and hospital |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 2 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Sunil Hanasi |
Rainbow Children s Hospital and Birthright |
Banjara hills Road number 2 . Hyderabad 500034
Hyderabad
TELANGANA |
9535573835
sunilhanasi@gmail.com |
| Dr Sunil Hanasi |
Rainbow Childrens Hospital and Birthright |
Department of Neonatology Second floor Rainbow Childrens Hospital and Birthright Road number 2 Banjara hills Hyderabad
Hyderabad
TELANGANA |
9535573835
sunilhanasi@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Rainbow Childrens Hospital and Birthright |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: P073||Preterm [premature] newborn [other], |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Serum ferritin level monitoring |
Oral iron suppllimentation guided by serum ferritin level monitoring from around 2 - 3 weeks of life till discharge from hospital |
| Comparator Agent |
Standard practice group |
Routine oral iron supplementation with empirical dosage and guided by hemoglobin level from 2-3 weeks of life till discharge from hospital |
|
|
Inclusion Criteria
|
| Age From |
0.00 Day(s) |
| Age To |
21.00 Day(s) |
| Gender |
Both |
| Details |
Neonates less than 32 weeks of gestational age hospitalized in NICU |
|
| ExclusionCriteria |
| Details |
Preterm neonates whom iron supplementation is deferred because as in
1.Those with an active, culture-proven infection, or positive sepsis screen
2.A major surgical malformation of gut
3.Neonates in whom bowel resection is done
4.Neonates with Stage II and III Necrotizing enterocolitis
5.Cyanotic congenital heart disease
6.Neonates with hemoglobinopathies.
7.Neonates diagnosed with inflammatory conditions like hemophagocytic lymphohistiosis (HLH).
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Determining the optimal age (in day of life) for initiation of oral iron supplementation at the time of full feed achievement and at 2 weeks of life (whichever is later) by serum ferritin monitoring compared with the standard practice. |
2 weeks to 4 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1.Total quantum (in mg) of oral iron supplemented during the NICU stay.
2.Number of LRBC transfusions administered during their stay in NICU.
3.Mean serum ferritin levels at the time of discharge in both groups.
|
At discharge (8-10 weeks) |
|
|
Target Sample Size
|
Total Sample Size="206"
Sample Size from India="206"
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)
|
12/05/2024 |
| 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="2"
Months="0"
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
|
•Iron
deficiency in preterm infants is associated with impaired motor, cognitive, and
behavioral development . Adequate
iron stores are essential for normal development of the dopaminergic axis,
myelination, and dendritic arborization .However, many preterm infants
develop iron deficiency due to decreased stores, rapid growth, and phlebotomy
losses •Conversely,
preterm infants are particularly susceptible to the pro-oxidant effects of
excess circulating iron because their antioxidant systems are immature. preterm complications like bronchopulmonary dysplasia, intraventricular
hemorrhage, and retinopathy of prematurity
are exacerbated by excess iron intake.
•Thus,
it is important to prevent both deficiency and excess by providing the optimal
amount and timing of iron intake for preterm infants. However,
optimal iron intake remains controversial.-The
American Academy of Pediatrics (AAP) recommends 2mg/kg/day of oral iron for
human milk-fed preterm infants at 4 weeks (except for those who received
transfusions),New
Zealand
& Australian Pediatrics society at 2- 3 weeks of age with 3 mg /kg/ day and
theEuropean
Society for Pediatric Gastroenterology Hepatology and Nutrition (ESPGHAN) at 2
weeks of age with 2-3mg/kg/day. European
Society for Pediatric Gastroenterology Hepatology and
Nutrition (ESPGHAN) 2022 - 23 •Since
individual iron status in VLBW infants is highly variable, depending on the
number of received blood transfusions and blood losses from phlebotomy, it is
recommended to follow these infants with repeated measurements of serum
ferritin •If
ferritin is <35–70 µg/L, the iron dose may be increased up to 3–4 (or maximum 6) mg/kg/d for a limited period.•If
ferritin is >300 µg/L, which in the absence of ongoing
inflammation and liver disease usually is the result of multiple blood
transfusions, iron supplementation and fortification should be discontinued until serum ferritin falls below
this level |