| CTRI Number |
CTRI/2019/03/018187 [Registered on: 20/03/2019] Trial Registered Prospectively |
| Last Modified On: |
02/01/2020 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cohort Study |
| Study Design |
Other |
|
Public Title of Study
|
"Iron status in moderate to late preterm babies" |
|
Scientific Title of Study
|
“Evaluation of iron status in moderate to late preterm infants receiving iron supplementation†- a prospective study. |
| Trial Acronym |
MLP Iron trial |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Alok Kumar M K |
| Designation |
Senior resident Department of neonatology |
| Affiliation |
Kerala institute of medical sciences, trivandrum |
| Address |
1, Vinod Nagar Rd, Anayara,Thiruvananthapuram, Kerala 695029
1, Vinod Nagar Rd, Anayara,Thiruvananthapuram, Kerala 695029
Thiruvananthapuram
KERALA
695029
India |
| Phone |
9986042757 |
| Fax |
|
| Email |
alokmk1988@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Naveen Jain |
| Designation |
Consultant Neonatology |
| Affiliation |
Kerala institute of medical sciences |
| Address |
1, Vinod Nagar Rd, Anayara,Thiruvananthapuram, Kerala 695029
1, Vinod Nagar Rd, Anayara,Thiruvananthapuram, Kerala 695029
Thiruvananthapuram
KERALA
695029
India |
| Phone |
9387814568 |
| Fax |
|
| Email |
naveen_19572@hotmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Naveen Jain |
| Designation |
Consultant Neonatology |
| Affiliation |
Kerala institute of medical sciences |
| Address |
1, Vinod Nagar Rd, Anayara,Thiruvananthapuram, Kerala 695029
1, Vinod Nagar Rd, Anayara,Thiruvananthapuram, Kerala 695029
Thiruvananthapuram
KERALA
695029
India |
| Phone |
9387814568 |
| Fax |
|
| Email |
naveen_19572@hotmail.com |
|
|
Source of Monetary or Material Support
|
| KIMS Hospital, trivandrum |
|
|
Primary Sponsor
|
| Name |
Alok Kumar M K |
| Address |
1, Vinod Nagar Rd, Anayara,Thiruvananthapuram, Kerala 695029 |
| Type of Sponsor |
Other [Self] |
|
|
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 |
| Alok Kumar M K |
KIMS hospital, Trinandrum |
Neonatology department, NICU, 5th Level, Main block,
1, Vinod Nagar Rd, Anayara,Thiruvananthapuram, Kerala 695029
Thiruvananthapuram
KERALA |
9986042757
alokmk1988@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional human ethics committee |
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
|
|
|
Inclusion Criteria
|
| Age From |
1.00 Day(s) |
| Age To |
14.00 Day(s) |
| Gender |
Both |
| Details |
1. Inborn neonates with gestation age between 32 weeks to 36 weeks (moderate to late preterm). |
|
| ExclusionCriteria |
| Details |
1. Blood transfusion within 6 weeks of birth
2. Babies who underwent exchange transfusion
3. Babies who underwent major surgery within 6 weeks of birth
4. Babies with twin to twin transfusion (monochorionic monoamniotic twins)
5. Sick babies who are not stable within 2 weeks of life |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Proportion of Moderate to late preterm babies having ID/IE at 14-16 weeks age while on standard iron supplementation. |
4 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Proportion of Moderate to late preterm babies with Iron deficiency anemia. |
4 months |
| Predictors of Iron deficiency and Anemia |
4 months |
| Proportion of MLP with growth parameters -2 Z score as per intergrowth charts. |
4 months |
| Proportion of MLP having abnormal General Movement Assessment at 14-16 weeks. |
4 months |
| Iron status and Development outcome. |
1 year |
|
|
Target Sample Size
|
Total Sample Size="152"
Sample Size from India="152"
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)
|
01/04/2019 |
| 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="3"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
None Yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Iron deficiency (ID) is the most common micronutrient deficiency worldwide. Preterm neonates are a special risk group because their rapid growth leads to high iron requirement.1-4 Iron is an essential micronutrient that plays a significant role in critical cellular functions in all organ systems of growing fetus and newborn. Studies have demonstrated poor cognitive and neurodevelopment outcome and increased morbidities like growth restriction and impaired immunity in rapidly growing infants with iron deficiency.1,5 Indian mothers are iron deficient and severe deficiency may have impact on fetal iron reserve.6 Delayed cord clamping (DCC) is now practiced in most units, this improves the iron transfer to babies at birth.7 However, iron excess may also have detrimental effects.1 Preterm infants are at increased risk of developing iron deficiency in early infancy as compared to term babies. For Very Low birth weight (VLBW) babies and babies with birth gestation <32weeks, there are definite evidence based recommendations regarding oral iron supplementation. There is paucity of data on routine iron supplementation in moderate to late preterm babies (MLP). Most recommendations are extrapolated from research on VLBW babies. Iron deficiency and iron excess (IE) can both be harmful; hence, there is a need to evaluate the appropriateness of routine oral iron supplementation.5 In our prospective study, we aim to evaluate the iron status of MLP at the age of 14-16 weeks age, while on standard oral iron supplementation (2mg/kg/day starting at 6 weeks of life). We also wish to evaluate the predictors of ID and impact of Iron status on growth profile and development in MLP. Inborn babies with birth gestation from 32 weeks to 36 weeks (MLP) will be eligible. Serum ferritin (SF) will be used as the measure of iron status in the body. The perinatal iron status will be measured as SF levels within 2 weeks of birth. All the babies will be started on iron supplementation (2mg/kg/day) at 6 weeks. We will evaluate the iron status (ID/IE) at 14-16 weeks while on standard oral iron supplementation. |