| CTRI Number |
CTRI/2024/04/065188 [Registered on: 04/04/2024] Trial Registered Prospectively |
| Last Modified On: |
18/10/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Implementation Research |
| Study Design |
Other |
|
Public Title of Study
|
Improving and testing a care package for small vulnerable infants in facility and community settings |
|
Scientific Title of Study
|
Low Birthweight and Preterm Infant Feeding Trial and Supportive Care Package (LIFT-UP): Implementation research of an in-facility and community supportive care package |
| Trial Acronym |
LIFT-UP |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Aarti Kumar |
| Designation |
CEO and Principal Scientist |
| Affiliation |
Community Empowerment Lab |
| Address |
Community Empowerment Lab, 1st Floor, CEO Room, A-6-14, Vineet Khand 6, Gomti Nagar
Lucknow, UTTAR PRADESH
226010 India
Lucknow
UTTAR PRADESH
226010
India |
| Phone |
919936060008 |
| Fax |
|
| Email |
aarti.kumar@celworld.org |
|
Details of Contact Person
Scientific Query
|
| Name |
Aarti Kumar |
| Designation |
CEO and Principal Scientist |
| Affiliation |
Community Empowerment Lab |
| Address |
Community Empowerment Lab, 1st Floor, CEO Room, A-6-14, Vineet Khand 6, Gomti Nagar
Lucknow, UTTAR PRADESH
226010 India
Lucknow
UTTAR PRADESH
226010
India |
| Phone |
919936060008 |
| Fax |
|
| Email |
aarti.kumar@celworld.org |
|
Details of Contact Person
Public Query
|
| Name |
Vinay Pratap Singh |
| Designation |
Director Research Management |
| Affiliation |
Community Empowerment Lab |
| Address |
Community Empowerment Lab, Ground Floor, Research
Management Room, A-6/14, Vineet Khand 6,
Gomti Nagar, Lucknow
UTTAR PRADESH 226010
India
Lucknow
UTTAR PRADESH
226010
India |
| Phone |
919818000252 |
| Fax |
|
| Email |
vinaypratap.singh@celworld.org |
|
|
Source of Monetary or Material Support
|
| Ariadne Labs
Harvard T.H. Chan School of Public Health
Harvard University, 401 Park Dr 3rd Floor, Boston, MA 02215, United States |
|
|
Primary Sponsor
|
| Name |
Harvard University |
| Address |
Harvard University, Boston Campus, 677 Huntington Ave, Boston, MA 02115, United States |
| Type of Sponsor |
Research institution |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Community Empowerment Lab |
F-09, 9th Floor, F-Block, Tower-B, Shalimar Grand, 10 Jopling Road, Lucknow - 226001 (India) |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 4 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Ms Aarti Kumar |
Community Empowerment Lab |
1st Floor, CEO Room, A-6 14, Vineet Khand 6,
Gomti Nagar, 226010 Lucknow UTTAR PRADESH
Lucknow
UTTAR PRADESH |
9936060009
aarti.kumar@celworld.org |
| Dr Arun Kumar Arya |
Ganesh Shankar Vidyarthi Memorial Medical College |
Department of Paediatrics, 1st Floor, HOD Room, Hallet Hospital under GSVM
Medical College, Swaroop Nagar 208002
Kanpur Nagar, UTTAR PRADESH
Kanpur Nagar
UTTAR PRADESH |
9451425801
arunped253@yahoo.com |
| Dr Ashok Kumar |
Institute of Medical Sciences Banaras Hindu University |
IMS, Banaras Hindu University, Department
of Paediatrics, 3rd Floor, Aurobindo Colony, Bhelupur 221005 Varanasi, UTTAR PRADESH
Kanpur Nagar
UTTAR PRADESH |
9415300370
ashokkumar_bhu@hotmail.com |
| Dr Mala Kumar |
King George’s Medical University |
Department of Paediatrics, Ground Floor, HOD Room, King Georges Medical University, Chowk, Lucknow UTTAR PRADESH 226003
Lucknow
UTTAR PRADESH |
9415470555
malakumar@kgmcindia.edu |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 4 |
| Name of Committee |
Approval Status |
| Banaras Hindu University Institutional Ethics Committee |
Approved |
| Community Empowerment Lab Institutional Ethics Committee |
Approved |
| Ethics Committee, GSVM Medical College Kanpur |
Approved |
| Institutional Ethics Committee KGMU Lucknow |
Submittted/Under Review |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: 8||Other Procedures, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
0.00 Day(s) |
| Age To |
27.00 Day(s) |
| Gender |
Both |
| Details |
1. LBW (less than 2.5 kg) or preterm (less than 37 weeks) infants admitted in the NICU of the study facility.
2. In-born infants admitted to the NICU within 24 hours of birth.
3. Mother and infant alive during screening
4. Mother consents for herself and infant
5.Women (mothers) who are 18+ years of age
6.All clinical study team members to be included with no exclusions. |
|
| ExclusionCriteria |
| Details |
1. Out-born infants referred to study facility NICU.
2. Congenital anomalies or acquired conditions that interfere with
feeding or placement of nasogastric or orogastric (NG or OG) tube
[e.g., cleft lip or palate, toxoplasmosis,other agents, rubella,
cytomegalovirus, and herpes (TORCH), Trisomy 21, Congenital
cardiac defect, neural tube defect, gastrointestinal (GI) tract
anomalies, hydrocephalus, NEC]
3. Severe birth asphyxia
4. Unknown date of birth and or unknown gestational age |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
1. Mean timing baby first fed mother breast milk post-birth
2. Mean time to mother first breast stimulation via first breast milk expression or baby first put to breast
3. Mean number of mother breast milk feeding sessions (direct or expressed) in the last 24 hours
4. Mean number of breast milk expression sessions in the last 24 hours
5. Maternal self-efficacy or confidence (different tools for those who expressed and those who fed directly at the breast) |
1. One time (Immediately after the enrolment and then daily till 14 days or discharge (Whichever is earlier)).
2. One time (Immediately after the enrolment and then daily till 14 days or discharge (Whichever is earlier)).
3. Daily till 14 days or discharge (Whichever is earlier).
4. Daily till 14 days or discharge (Whichever is earlier).
5. Last day i.e. 14th day or on the day of discharge whichever is earlier. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. Mean timing of baby first fed mother breast milk post-NICU admission
2. Management of feeding difficulties
3. Percentage receiving at least 8 hours of KMC in last 24 hours)
4. Any KMC in last 24 hours
5. Percentage Infant fed exclusive MOM in the last 24 hours
6. Mean weight velocity (growth) (g per kg per day) |
Daily or till the discharge of newborn or 14 days after admission |
|
|
Target Sample Size
|
Total Sample Size="360"
Sample Size from India="240"
Final Enrollment numbers achieved (Total)= "43"
Final Enrollment numbers achieved (India)="43" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
01/07/2024 |
| Date of Study Completion (India) |
28/02/2025 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="6"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
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 "LIFT-UP’’ study focuses on addressing the challenges posed by low birth weight (LBW), very low birth weight (VLBW) and preterm gestation newborns, particularly in Low and Middle-Income Countries (LMICs) like India and some of the African countries etc. These babies are more likely to have health problems, and it can affect their growth and development. This research has been initiated by Ariadne Labs at the Harvard School of Public Health (HSPH), and will be conducted in India (UP and Karnataka), Malawi, and Tanzania. The overarching study has multiple objectives, and the study in UP will be focused on the following: (i) To refine and evaluate a co-designed specialized “infacility feeding support plus†package (lactation/ human milk feeding support and management with KMC & WASH) along with its delivery approach to LBW or preterm infants and their families through health providers in routine NICU facility settings. (ii) To refine and evaluate a co-designed, scalable specialized transition-to-home “community feeding support plus†package (lactation and feeding counseling and support with KMC and WASH) along with its delivery approach to mothers and their LBW or preterm infants discharged from NICU facilities in routine community settings through existing community health workers. Specifically, our goal through this implementation research would be the development of an effective and scalable package that can be implemented within facility and community settings to support the comprehensive care of preterm/ LBW infants throughout the facility-community continuum. While Objective 1 of the study will be conducted simultaneously across India (UP), Malawi and Tanzania and elements of the co-designed and refined package will be harmonized across the three sites, Objective 2 of the study will only be conducted in India (UP). In India, the study will be conducted in partnership with medical colleges with level-3 hospitals in three districts. This is an implementation research, and the co-developed facility and community-based feeding support strategies will be concurrently evaluated and optimized to improve provider behaviors, and maternal and family practices to achieve optimal feeding and care of newborns and ensure its feasibility and acceptability. |