| CTRI Number |
CTRI/2024/06/068731 [Registered on: 11/06/2024] Trial Registered Prospectively |
| Last Modified On: |
11/06/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cohort Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Chances of very premature babies having abnormal serum zinc levels |
|
Scientific Title of Study
|
Proportion of very preterm neonates with abnormal serum zinc levels: A Prospective observational study. |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Abhishek N |
| Designation |
Senior Resident, Neonatology |
| Affiliation |
KIMSHealth, Thiruvananthapuram. |
| Address |
Neonatology department,
Level 4, KIMS east building,
KIMSHealth Hospital
Vinod Nagar road
Anayara
Thiruvananthapuram.
Thiruvananthapuram
KERALA
695029
India |
| Phone |
8553978178 |
| Fax |
|
| Email |
abhishekn.bly@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Naveen Jain |
| Designation |
Coordinator and Senior Consultant Neonatology. |
| Affiliation |
KIMSHealth, Thiruvananthapuram. |
| Address |
Neonatology Department,
Level 4, KIMS east building,
KIMSHealth hospital,
Vinod Nagar road,
Anayara,
Thiruvananthapuram.
Thiruvananthapuram
KERALA
695029
India |
| Phone |
9387814568 |
| Fax |
|
| Email |
naveen_19572@hotmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Abhishek N |
| Designation |
Senior Resident, Neonatology |
| Affiliation |
KIMSHealth, Thiruvananthapuram. |
| Address |
Neonatology department,
Level 4, KIMS east building,
KIMSHealth hospital,
Vinod nagar road,
Anayara,
Thiruvananthapuram.
Thiruvananthapuram
KERALA
695029
India |
| Phone |
8553978178 |
| Fax |
|
| Email |
abhishekn.bly@gmail.com |
|
|
Source of Monetary or Material Support
|
| KIMShealth Hospital
Vinod nagar road,
Anayara,
Thiruvananthapuram.
Pin: 695029
Kerala,
India. |
|
|
Primary Sponsor
|
| Name |
KIMSHealth |
| Address |
KIMSHealth Hospital,
Anayara,
Thiruvananthapuram - 695029. |
| Type of Sponsor |
Private hospital/clinic |
|
|
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 |
| Dr Naveen Jain |
KIMSHealth hospital |
NICU, Neonatology department, Level 4, KIMS east building,
Vinod nagar road, Anayara,
Thiruvananthapuram.
Pin- 695029
Thiruvananthapuram
KERALA |
9387814568
naveen_19572@hotmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Human Ethics Committee, KIMSHealth Hospital, Thiruvananthapuram. |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: P09||Abnormal findings on neonatal screening, (2) ICD-10 Condition: P070||Extremely low birth weight newborn, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
nil |
Not applicable as this is an observational study. |
| Comparator Agent |
NIL |
Not applicable as this is an observational study. |
|
|
Inclusion Criteria
|
| Age From |
0.00 Day(s) |
| Age To |
28.00 Day(s) |
| Gender |
Both |
| Details |
1) preterm neonates less than or equal to 32 weeks of gestation at birth.
2) Who are offered standard care and who complete their care in the unit till time point of measurement of primary outcome i.e. at least 1 week of full enteral feeds. |
|
| ExclusionCriteria |
| Details |
1) Babies who were transferred out before completion of care, whose primary outcome is not retrievable after transfer.
2) If parents/guardians doesn’t give consent for the study. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Proportion of very preterm with low zinc levels |
1 week after full enteral feeds |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Association between abnormal serum zinc and serum ferritin levels. |
1 week after full enteral feeds |
| Association between abnormal serum zinc levels and gestational age, birth weight, IUGR, sepsis, NEC, ROP requiring laser, BPD and mortality. |
During NICU stay |
| Association between abnormal serum zinc levels in babies who received parentral nutrition vs only enteral nutrition |
1 week after full enteral feeds |
|
|
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)
|
22/06/2024 |
| 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="1"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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
|
Zinc is the 2nd most abundant active trace element in human body after iron. It is essential in growth and tissue differentiation via gene transcription, metabolism of macronutrients and hormonal activity. Preterm infants are at high risk for zinc deficiency due to low body stores, increased renal and intestinal losses, low intake and high demand due to high growth velocity. Zinc deficiency in preterm is associated with stunted growth, increased risk of infections, skin rash and possibly poor neurodevelopment. There are limited studies on serum zinc levels in preterm babies in early postnatal life and adequacy of current zinc supplementation policy in very preterm babies is largely unknown. Relation between zinc deficiency and morbidities like NEC, MBD, ROP, BPD, infections and brain injury is not well established. This study is a prospective observational study in preterm less than or equal to 32 weeks, includes collection of data at defined timepoints. Serum zinc values which are measured at least after 1 week of attaining full enteral feeds - 100ml/kg/day will be retrieved and assessed in study population. Relevant antenatal, postnatal history, demographic details, clinical data and investigations will be collected in a predefined proforma. |