| CTRI Number |
CTRI/2017/01/007702 [Registered on: 13/01/2017] Trial Registered Retrospectively |
| Last Modified On: |
18/11/2019 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [Nutritional] |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Introduction of solid foods to preterm infants |
|
Scientific Title of Study
|
Starting Complementary Feeds in Preterms (The SCIP study) |
| Trial Acronym |
SCIP |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| U1111-1189-8078 |
UTN |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Latha Sashi |
| Designation |
Consultant Nutritionist |
| Affiliation |
Fernandez Hospital |
| Address |
4-1-1230, Bogulkunta, Near Abids, Hyderabad. Telangana
Hyderabad
ANDHRA PRADESH
500001
India |
| Phone |
9848135621 |
| Fax |
914024753487 |
| Email |
drlatha_s@fernandezhospital.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Latha Sashi |
| Designation |
Consultant Nutritionist |
| Affiliation |
Fernandez Hospital |
| Address |
4-1-1230, Bogulkunta, Near Abids, Hyderabad. Telangana
Hyderabad
ANDHRA PRADESH
500001
India |
| Phone |
9848135621 |
| Fax |
914024753487 |
| Email |
drlatha_s@fernandezhospital.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Latha Sashi |
| Designation |
Consultant Nutritionist |
| Affiliation |
Fernandez Hospital |
| Address |
4-1-1230, Bogulkunta, Near Abids, Hyderabad. Telangana
Hyderabad
ANDHRA PRADESH
500001
India |
| Phone |
9848135621 |
| Fax |
914024753487 |
| Email |
drlatha_s@fernandezhospital.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Fernandez Hospital |
| Address |
4-1-1230, Bogulkunta, Near Abids, Hyderabad, Telangana, 500001 |
| Type of Sponsor |
Research institution and hospital |
|
|
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 Latha Sashi |
Fernandez Hospital unit 2 |
3-6-282, Opp. Old MLA Quarters, Hyderguda, Hyderabad, Telangana 500029
Hyderabad
ANDHRA PRADESH |
9848135621
drlatha_s@fernandezhospital.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Fernandez ethics committee, IRB registered with the Office of Human Research Protection, Bethesda USA with a IORG reference number 0004763 |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
Preterm infants, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Delayed initiation of solid complementary feeds |
Parents are advised to initiate solid complementary feeds between 15-17 weeks corrected age. |
| Intervention |
Early initiation of solid complementary feeds |
Parents are advised to initiate solid complementary feeds between 11-13 weeks corrected age. |
|
|
Inclusion Criteria
|
| Age From |
3.00 Month(s) |
| Age To |
1.00 Year(s) |
| Gender |
Both |
| Details |
Preterm infants born at Fernandez Hospital whose parents provide informed consent.
Preterm defined as infants born before 34 weeks period of gestation.
|
|
| ExclusionCriteria |
| Details |
Infants on solid feeds prior to 11 weeks corrected age and infants with diseases affecting growth and feeding; which includes those with a history of gastrointestinal disorders, congenital birth defects, bronchopulmonary disorders, congenital heart defects, chromosomal abnormalities and neurologic abnormalities |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Weight |
1 year corrected age |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Height |
1 year corrected age |
| Occipito frontal circumference |
1 year corrected age |
| Body mass index |
1 year corrected age |
| Mid-upper arm circumference |
1 year corrected age |
| Hemoglobin |
1 year corrected age |
| Serum ferritin |
1 year corrected age |
| Serum vitamin D |
1 year corrected age |
| Serum calcium |
1 year corrected age |
| Packed cell volume |
1 year corrected age |
| History of eczema |
1 year corrected age |
|
|
Target Sample Size
|
Total Sample Size="290"
Sample Size from India="290"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="0" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
23/11/2016 |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="2"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
None yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
This is an open label randomised control trial comparing and evaluating the effect of early and delayed introduction of solid feeds on growth, haematological and biochemical markers in preterm infants. Preterm infants are more vulnerable to growth failure as they need to meet the nutrient losses accrued due to premature birth. They have higher energy and nutrient requirements than appropriate for gestational age infants and hence require enhanced nutritional support. Some of the previous studies on preterm neonates concluded that early weaning will help in decreasing the caloric deficit and also improves the growth outcomes. It has also shown to improve the iron stores. Many mothers in our practice have started these feeds at 4-6 months of post natal age. However it is not concluded as to how early we can start these feeds. In this RCT, the researchers want to look at two different ages for starting complementary feeds to improve the growth outcomes. |