Very Preterm InfantLIFT-UP RCTNCT06765863
LIFT-UP: Randomized Controlled Trial of Fortification of Human Milk
A study testing Human Milk Fortifier and Volume targets in people with Very Preterm Infant and Very Low Birthweight, run by Harvard School of Public Health (HSPH) at 4 sites in India.
Trial summary
The goal of the LIFT-UP randomized controlled trial is to evaluate the efficacy of feeding routinely and fortified human milk using a standardized clinical protocol to very low birthweight (VLBW) or very preterm (VPT) infants in the NICU compared to not feeding routinely fortified human milk using the standardized… Read more about this study
- Who is it for?
- Ages Up to 48 hoursHealthy volunteers can take part
- Conditions the study is for
- Very Preterm Infant, Very Low Birthweight
- What is being tested?
- Human Milk Fortifier and Volume targets
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 776 participants
- Where
- 4 sitesIndia
- Study dates
- 16 Jan 2025to 31 Mar 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 48 hours
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Very LBW (≤1.5kg)* or very preterm (≤32 weeks) infants admitted to NICU at study facility within 24 hours of birth for in-born infants and up to 48 hours for out-born**
- Mother and infant alive during screening
- Mother age 18+ years
- Lives within catchment areas of the facility
- Mother intends to stay in catchment area of the study facility for at least 3 months
- At randomization: Infant receiving at least 60 mL/kg/day of human milk***
Who cannot join
- Lives outside the defined catchment area
- Congenital abnormalities or acquired conditions that interfere with feeding or placement of nasogastric/orogastric tube [cleft lip/palate, toxoplasmosis, other agents, rubella, cytomegalovirus, and herpes (TORCH), Trisomy 21, congenital cardiac defect, neural tube defect, gastrointestinal tract anomalies, hydrocephalus, NEC]
- Severe birth asphyxia
- Critically ill (i.e. not on enteral feeds)
- Unknown date of birth and unknown gestational age
Trial locations and contacts
4 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Linda Vesel, PhD, MPH contact
India4 sites, 4 recruiting
- Recruiting
Ballari Medical College and Research Centre
Ballary, Karnataka
Durgappa, MD
- Not yet recruiting
KLES Dr Prabhakar Kore Hospital & Medical Research Center
Belagavi, Karnataka
Roopa Bellad, MD
Roopa Bellad, MD
- Recruiting
JJM Medical College
Davangere, Karnataka
Gowdar Guruprasad, MD, DCH, DNB, DM
- Recruiting
Niloufer Hospital
Hyderabad, Telangana
Swapna Lingaldinna, MBBS, +91 98480 82441, drswapnalingadinna@gmail.com
About this study
Official title: Low Birthweight and Preterm Infant Feeding Trial and Supportive Care Package (LIFT-UP): Randomized Controlled Trial of In-facility Fortification of Human Milk in India
The goal of the LIFT-UP randomized controlled trial is to evaluate the efficacy of feeding routinely and fortified human milk using a standardized clinical protocol to very low birthweight (VLBW) or very preterm (VPT) infants in the NICU compared to not feeding routinely fortified human milk using the standardized clinical protocol.
The primary research question is: Will VLBW or VPT infants in the NICU who are fed fortified human milk using a standardized feeding protocol have better growth outcomes by facility discharge and at 3 months of age, less illness by discharge, and decreased mortality by discharge and at one month compared to those who are not routinely fed fortified human milk using the same feeding protocol?
Read the detailed description
AIM: To improve feeding and growth outcomes among very low birthweight (LBW; ≤1.5kg) or very preterm (≤32 weeks gestational age) infants admitted to neonatal intensive care units (NICU) in India through fortification of human milk.
OBJECTIVE: To evaluate (via individually randomized controlled study) the efficacy of feeding routinely and fortified human milk using a standardized clinical protocol to very LBW or very preterm infants in the NICU compared to not feeding routinely fortified human milk using the standardized clinical protocol.
STUDY DESIGN This study is a multi-site individually randomized prospective trial among VLBW or VPT infants admitted to the NICU in study facilities who consume human milk and meet eligibility criteria (along with their mothers).
SCREENING AND ENROLLMENT All infants admitted to the NICU and their mothers will be screened for study eligibility. Screening will be performed within 24 hours of birth for inborn infants and within 48 hours of birth for outborn infants. Eligible dyads with the intention to feed human milk [mother's own milk (MOM) or pasteurized donor human milk (PDHM)] whose mothers provide consent will be enrolled into the study.
Once the mother-infant dyad is enrolled and prior to randomization, they will:
Receive the guideline-driven standard of care and be provided access to breast pumps to help initiate and advance breast milk feeding. The guideline-driven standard of care includes facility-based lactation support/feeding counseling + KMC + WASH components designed specifically for small vulnerable newborns and was developed as part of a different study protocol (see NCT06390943).
Adhere to a clinical guideline including targets for initiating and advancing breast milk feeding. Initially, this clinical guideline will help infants achieve breast milk volume intake of at least 60 mL/kg/day, the primary criterion for randomization. After randomization, the clinical guideline will continue to support advancing human milk feeding for all infants advance to 180 mL/kg/day.
RANDOMIZATION Once an infant consumes at least 60 mL/kg/day of breast milk, enrolled dyads will be assessed for eligibility for randomization. Eligible dyads will be randomized individually in a 1:1 ratio to either the intervention or comparison arm. Randomization sequences will be previously generated by the study statistician. If an infant does not consume at least 60 mL/kg/day of breastmilk by day 10 of chronological age, the mother-infant dyad will be administratively withdrawn from the study.
DELIVERY OF INTERVENTION Mothers of infants randomized to the intervention arm will express their breast milk into a standardized measurement cup (or PDHM can be used). Clinical research staff will mix human milk fortifier (HMF) in human milk (either MOM or PDHM, if available) per manufacturer specifications per feed for a minimum of 21 days.
Dyads in both arms will continue to receive the guideline-driven standard of care, access to breast pumps, and follow the volume target and trajectory protocol until they meet stopping criteria. Data will be collected every 24 hours, including a log at every feed, regardless of study arm assignment.
If an infant in either arm does not meet protocolized minimum volume targets or trajectories AND that infant meets weight-based safety net criteria, clinicians will intervene per judgment aligned with national and local protocols.
The intervention will not be continued once the infant meets stopping criteria with the goal of the infant having fully transitioned to exclusive breast milk feeding by then.
STOPPING CRITERIA After the minimum duration of 21 days post-randomization, hospitalized infants should continue to receive volume targeted feeding with or without HMF for as long as they receive expressed breast milk. Once infants transition to full, direct breastfeeding in preparation for discharge or are being discharged per clinician discretion, they will stop adhering to the volume targets and infants in the intervention group will stop receiving fortified human milk.
DISCHARGE FROM FACILITY TO HOME After stopping criteria are met, routine clinical care around infant feeding will be provided. Infants can be discharged home when deemed clinically appropriate per facility protocols and clinician judgment. The guideline-driven standard of care will encourage all mothers to exclusively breastfeed their infants prior to discharge and to continue doing so after discharge.
POST-DISCHARGE FACILITY VISITS All dyads will be followed up at 2 weeks of age, 4 weeks of age, and 3 months of chronological age.
- Conditions
- Very Preterm Infant, Very Low Birthweight
- Being tested
- Human Milk Fortifier, Volume targets
- Keywords
- very preterm, very low birthweight, fortification, human milk
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Human Milk FortifierDietary supplement
Also called Volume targets, Guideline-driven standard of care
Human milk fortifier added to expressed human milk (mother's own milk or pasteurized donor human milk) per feed per manufacturer's instructions for a minimum of 21 days (in-facility provision only)
- Clinical feeding guideline including targets for initiation and advancement of breast milk feeding
- Provision of guideline-driven standard of care [facility-based lactation support/feeding counseling + KMC + WASH package (referred to as facility-based FSP+) and breast pumps]
Volume targetsOther
Also called Guideline driven standard of care
- Clinical feeding guideline including targets for initiation and advancement of breast milk feeding
- Provision of guideline-driven standard of care [facility-based lactation support/feeding counseling + KMC + WASH package (referred to as facility-based FSP+) and breast pumps]
| Study group | Role | What they receive |
|---|---|---|
| Routine fortification of human milk with human milk fortifier using a standardized clinical protocol | Experimental | Enrolled participants in the intervention arm will be exposed to:
* Provision of guideline-driven standard of care specifically for VPT/ VLBW babies
* Encouragement to express breast milk with breast pumps
* Adherence to a clinical guideline including targets for initiation and advancement of breast milk feeding for VPT/ VLBW babies based on birthweight
* Fortification of human milk with HMF
* Adherence to standardized stopping criteria (i.e., stopping adherence to clinical feeding guideline AND stopping routine fortification of human milk) Receives: Dietary Supplement: Human Milk Fortifier; Other: Volume targets |
| No routine fortification of human milk using a standardized clinical protocol | Active comparator | Participants in the control group will have the same exposures as the participants in the intervention group EXCEPT for the human milk consumed will not be fortified with HMF.
* Provision of guideline-driven standard of care specifically for VPT/ VLBW babies
* Encouragement to express with breast pumps
* Adherence to a clinical guideline including targets for initiation and advancement of breast milk feeding for VPT/ VLBW babies based on birthweight
* Adherence to standardized stopping criteria (i.e., stopping adherence to clinical feeding guideline) Receives: Other: Volume targets |
What is being measured
The primary outcome is the main question the study is designed to answer.
Length-for-age Z score (LAZ)
Mean LAZ (SD, range) measured at birth, 2 weeks, 4 weeks and 3 months of age
Measured: 3 Months
Secondary outcomes (18)
Length of Stay
Mean (SD) number of days admitted in the study facility from randomization to facility discharge
Measured: From date of randomization until the date of facility discharge or date of death from any cause, whichever came first, assessed up to 3 months of age.
Feeding intolerance
% infants identified with feeding intolerance
Measured: From randomization to facility discharge, assessed up to 3 months of age
Weight growth velocity
% infants attaining 15 g/kg/day
Measured: From randomization to facility discharge, assessed up to 3 months of age
Length gain
Mean (SD) change in length (mm/week)
Measured: From randomization to facility discharge, assessed up to 3 months of age.
Head circumference gain
Mean (SD) change in head circumference (mm per week)
Measured: From randomization to facility discharge, assessed up to 3 months of age
Necrotizing enterocolitis (NEC)
% infants diagnosed with NEC
Measured: From randomization to facility discharge, assessed up to 3 months of age.
Sepsis/possible serious bacterial infection (PSBI)
% diagnosed with sepsis or possible serious bacterial infection (PSBI)
Measured: From randomization to facility discharge, assessed up to 3 months of age
Infant mortality
% infants died
Measured: From randomization to 3 months of age
Birthweight regain
% infants who regain birthweight by 2 weeks of age
Measured: 2 weeks of age
Mean weight growth velocity (4 weeks)
Mean (SD) change in weight (growth) at 4 weeks of age
Measured: From randomization to 4 weeks of age
Neonatal mortality (4 weeks)
% of neonates who died up to 4 weeks of age
Measured: From randomization to 4 weeks of age
Sepsis/possible serious bacterial infection (PSBI, 4 weeks)
% of infants diagnosed with sepsis/PSBI up to 4 weeks of age
Measured: From randomization to 4 weeks of age
Mean weight growth velocity
Mean change in infant weight (growth) calculated in grams/kilogram/day (g/kg/day)
Measured: From randomization to facility discharge, assessed up to 3 months of age.
Weight-for-age Z score (WAZ)
Mean (SD) WAZ at 3 months of age
Measured: 3 months of age
Weight-for-length Z score (WLZ)
Mean (SD) weight-for-length Z score (WLZ) at 3 months of age
Measured: 3 months of age
Head circumference-for-age Z score (HcAZ)
Mean (SD) HcAZ
Measured: 3 months of age
Change in WAZ
Change in WAZ from randomization to 3 months of age
Measured: From randomization to 3 months of age
Change in LAZ
Change in LAZ from randomization to 3 months of age
Measured: From randomization to 3 months of age
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jan 2025
- Study start16 Jan 2025
- Primary completion31 Mar 2027 (estimated)
- Study completion31 Mar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Very Preterm InfantStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Mother-infant dyads will be individually randomized 1:1 to the intervention or comparison arm.
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 776 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Harvard School of Public Health (HSPH)
- Sponsor type
- University, hospital or other
- Collaborators
- Boston Children's Hospital, Brigham and Women's Hospital, Emory University, Muhimbili University of Health and Allied Sciences, Jawaharlal Nehru Medical College, PATH, University of North Carolina
- Responsible party
- Principal investigator, Katherine Semrau, Harvard School of Public Health (HSPH)
- Investigators
- Katherine Semrau, PhD, MPH, Principal investigator, Ariadne Labs | Harvard TH Chan School of Public Health and Brigham and Womens Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06765863
- Sponsor's protocol ID
- IRB23-0304
- Acronym
- LIFT-UP RCT
- Status last verified
- Jan 2026
- First submitted
- 26 Dec 2024
- Last updated
- 21 Jan 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified datasets will be released after the close of the project in a data sharing repository, such as Harvard Dataverse or similar, in a format readable by analytics tools. Harvard Dataverse is an online data repository where you can share, preserve, cite, explore, and analyze research data. Datasets and data dictionaries will be provided in compliance with the ethical review board requirements. As part of the Harvard Dataverse system, registration to download datasets is required. External partners (those not involved in the study) must provide their contact information and describe their intention of data use.
Study at a glance
From the registry record, last updated by the sponsor on 21 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Low Birthweight and Preterm Infant Feeding Trial and Supportive Care Package (LIFT-UP): Randomized Controlled Trial of In-facility Fortification of Human Milk in India
- ClinicalTrials.gov ID
- NCT06765863
- Acronym / sponsor ID
- LIFT-UP RCT / IRB23-0304
- Conditions
- Very Preterm Infant, Very Low Birthweight
- Keywords
- very preterm, very low birthweight, fortification, human milk
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 776 participants (estimated)
- Lead sponsor
- Harvard School of Public Health (HSPH)University, hospital or other
- Collaborators
- Boston Children's Hospital, Brigham and Women's Hospital, Emory University, Muhimbili University of Health and Allied Sciences, Jawaharlal Nehru Medical College, PATH, University of North Carolina
- Study start
- 16 Jan 2025 (actual)
- Primary completion
- 31 Mar 2027 (estimated)
- Study completion
- 31 Mar 2027 (estimated)
- First posted
- 9 Jan 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of the LIFT-UP randomized controlled trial is to evaluate the efficacy of feeding routinely and fortified human milk using a standardized clinical protocol to very low birthweight (VLBW) or very preterm (VPT) infants in the NICU compared to not feeding routinely fortified human milk using the standardized clinical protocol.
The primary research question is: Will VLBW or VPT infants in the NICU who are fed fortified human milk using a standardized feeding protocol have better growth outcomes by facility discharge and at 3 months of age, less illness by discharge, and decreased mortality by discharge and at one month compared to those who are not routinely fed fortified human milk using the same feeding protocol?
Detailed description
AIM: To improve feeding and growth outcomes among very low birthweight (LBW; ≤1.5kg) or very preterm (≤32 weeks gestational age) infants admitted to neonatal intensive care units (NICU) in India through fortification of human milk.
OBJECTIVE: To evaluate (via individually randomized controlled study) the efficacy of feeding routinely and fortified human milk using a standardized clinical protocol to very LBW or very preterm infants in the NICU compared to not feeding routinely fortified human milk using the standardized clinical protocol.
STUDY DESIGN This study is a multi-site individually randomized prospective trial among VLBW or VPT infants admitted to the NICU in study facilities who consume human milk and meet eligibility criteria (along with their mothers).
SCREENING AND ENROLLMENT All infants admitted to the NICU and their mothers will be screened for study eligibility. Screening will be performed within 24 hours of birth for inborn infants and within 48 hours of birth for outborn infants. Eligible dyads with the intention to feed human milk [mother's own milk (MOM) or pasteurized donor human milk (PDHM)] whose mothers provide consent will be enrolled into the study.
Once the mother-infant dyad is enrolled and prior to randomization, they will:
Receive the guideline-driven standard of care and be provided access to breast pumps to help initiate and advance breast milk feeding. The guideline-driven standard of care includes facility-based lactation support/feeding counseling + KMC + WASH components designed specifically for small vulnerable newborns and was developed as part of a different study protocol (see NCT06390943).
Adhere to a clinical guideline including targets for initiating and advancing breast milk feeding. Initially, this clinical guideline will help infants achieve breast milk volume intake of at least 60 mL/kg/day, the primary criterion for randomization. After randomization, the clinical guideline will continue to support advancing human milk feeding for all infants advance to 180 mL/kg/day.
RANDOMIZATION Once an infant consumes at least 60 mL/kg/day of breast milk, enrolled dyads will be assessed for eligibility for randomization. Eligible dyads will be randomized individually in a 1:1 ratio to either the intervention or comparison arm. Randomization sequences will be previously generated by the study statistician. If an infant does not consume at least 60 mL/kg/day of breastmilk by day 10 of chronological age, the mother-infant dyad will be administratively withdrawn from the study.
DELIVERY OF INTERVENTION Mothers of infants randomized to the intervention arm will express their breast milk into a standardized measurement cup (or PDHM can be used). Clinical research staff will mix human milk fortifier (HMF) in human milk (either MOM or PDHM, if available) per manufacturer specifications per feed for a minimum of 21 days.
Dyads in both arms will continue to receive the guideline-driven standard of care, access to breast pumps, and follow the volume target and trajectory protocol until they meet stopping criteria. Data will be collected every 24 hours, including a log at every feed, regardless of study arm assignment.
If an infant in either arm does not meet protocolized minimum volume targets or trajectories AND that infant meets weight-based safety net criteria, clinicians will intervene per judgment aligned with national and local protocols.
The intervention will not be continued once the infant meets stopping criteria with the goal of the infant having fully transitioned to exclusive breast milk feeding by then.
STOPPING CRITERIA After the minimum duration of 21 days post-randomization, hospitalized infants should continue to receive volume targeted feeding with or without HMF for as long as they receive expressed breast milk. Once infants transition to full, direct breastfeeding in preparation for discharge or are being discharged per clinician discretion, they will stop adhering to the volume targets and infants in the intervention group will stop receiving fortified human milk.
DISCHARGE FROM FACILITY TO HOME After stopping criteria are met, routine clinical care around infant feeding will be provided. Infants can be discharged home when deemed clinically appropriate per facility protocols and clinician judgment. The guideline-driven standard of care will encourage all mothers to exclusively breastfeed their infants prior to discharge and to continue doing so after discharge.
POST-DISCHARGE FACILITY VISITS All dyads will be followed up at 2 weeks of age, 4 weeks of age, and 3 months of chronological age.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Mother-infant dyads will be individually randomized 1:1 to the intervention or comparison arm.
| Arm | Type | Receives |
|---|---|---|
| Routine fortification of human milk with human milk fortifier using a standardized clinical protocol | Experimental | Dietary Supplement: Human Milk Fortifier, Other: Volume targetsEnrolled participants in the intervention arm will be exposed to: * Provision of guideline-driven standard of care specifically for VPT/ VLBW babies * Encouragement to express breast milk with breast pumps * Adherence to a clinical guideline including targets for initiation and advancement of breast milk feeding for VPT/ VLBW babies based on birthweight * Fortification of human milk with HMF * Adherence to standardized stopping criteria (i.e., stopping adherence to clinical feeding guideline AND stopping routine fortification of human milk) |
| No routine fortification of human milk using a standardized clinical protocol | Active comparator | Other: Volume targetsParticipants in the control group will have the same exposures as the participants in the intervention group EXCEPT for the human milk consumed will not be fortified with HMF. * Provision of guideline-driven standard of care specifically for VPT/ VLBW babies * Encouragement to express with breast pumps * Adherence to a clinical guideline including targets for initiation and advancement of breast milk feeding for VPT/ VLBW babies based on birthweight * Adherence to standardized stopping criteria (i.e., stopping adherence to clinical feeding guideline) |
Who may qualify
- Ages
- Up to 48 hours
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- Very LBW (≤1.5kg)* or very preterm (≤32 weeks) infants admitted to NICU at study facility within 24 hours of birth for in-born infants and up to 48 hours for out-born**
- Mother and infant alive during screening
- Mother age 18+ years
- Lives within catchment areas of the facility
- Mother intends to stay in catchment area of the study facility for at least 3 months
Key exclusion criteria (5 listed)
- Lives outside the defined catchment area
- Congenital abnormalities or acquired conditions that interfere with feeding or placement of nasogastric/orogastric tube [cleft lip/palate, toxoplasmosis, other agents, rubella, cytomegalovirus, and herpes (TORCH), Trisomy 21, congenital cardiac defect, neural tube defect, gastrointestinal tract anomalies, hydrocephalus, NEC]
- Severe birth asphyxia
- Critically ill (i.e. not on enteral feeds)
- Unknown date of birth and unknown gestational age
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Human Milk FortifierAlso: Volume targets, Guideline-driven standard of careHuman milk fortifier added to expressed human milk (mother's own milk or pasteurized donor human milk) per feed per manufacturer's instructions for a minimum of 21 days (in-facility provision only) * Clinical feeding guideline including targets for initiation and advancement of breast milk feeding * Provision of guideline-driven standard of care [facility-based lactation support/feeding counseling + KMC + WASH package (referred to as facility-based FSP+) and breast pumps] | Dietary supplement | Routine fortification of human milk with human milk fortifier using a standardized clinical protocol |
| Volume targetsAlso: Guideline driven standard of care* Clinical feeding guideline including targets for initiation and advancement of breast milk feeding * Provision of guideline-driven standard of care [facility-based lactation support/feeding counseling + KMC + WASH package (referred to as facility-based FSP+) and breast pumps] | Other | No routine fortification of human milk using a standardized clinical protocol, Routine fortification of human milk with human milk fortifier using a standardized clinical protocol |
Primary outcome
Length-for-age Z score (LAZ)
Time frame: 3 Months
Mean LAZ (SD, range) measured at birth, 2 weeks, 4 weeks and 3 months of age
18 secondary outcomes
Length of Stay
Time frame: From date of randomization until the date of facility discharge or date of death from any cause, whichever came first, assessed up to 3 months of age.
Feeding intolerance
Time frame: From randomization to facility discharge, assessed up to 3 months of age
Weight growth velocity
Time frame: From randomization to facility discharge, assessed up to 3 months of age
Length gain
Time frame: From randomization to facility discharge, assessed up to 3 months of age.
Head circumference gain
Time frame: From randomization to facility discharge, assessed up to 3 months of age
Necrotizing enterocolitis (NEC)
Time frame: From randomization to facility discharge, assessed up to 3 months of age.
Sepsis/possible serious bacterial infection (PSBI)
Time frame: From randomization to facility discharge, assessed up to 3 months of age
Infant mortality
Time frame: From randomization to 3 months of age
Birthweight regain
Time frame: 2 weeks of age
Mean weight growth velocity (4 weeks)
Time frame: From randomization to 4 weeks of age
Neonatal mortality (4 weeks)
Time frame: From randomization to 4 weeks of age
Sepsis/possible serious bacterial infection (PSBI, 4 weeks)
Time frame: From randomization to 4 weeks of age
Mean weight growth velocity
Time frame: From randomization to facility discharge, assessed up to 3 months of age.
Weight-for-age Z score (WAZ)
Time frame: 3 months of age
Weight-for-length Z score (WLZ)
Time frame: 3 months of age
Head circumference-for-age Z score (HcAZ)
Time frame: 3 months of age
Change in WAZ
Time frame: From randomization to 3 months of age
Change in LAZ
Time frame: From randomization to 3 months of age
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jan 2026.
- Individual participant dataSharing planned: Yes. De-identified datasets will be released after the close of the project in a data sharing repository, such as Harvard Dataverse or similar, in a format readable by analytics tools. Harvard Dataverse is an online data repository where you can share, preserve, cite, explore, and analyze research data. Datasets and data dictionaries will be provided in compliance with the ethical review board requirements. As part of the Harvard Dataverse system, registration to download datasets is required. External partners (those not involved in the study) must provide their contact information and describe their intention of data use.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Linda Vesel, PhD, MPH contact
Katherine Semrau, PhD, MPH principal investigator
Ariadne Labs | Harvard TH Chan School of Public Health and Brigham and Womens Hospital
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Human Milk Fortifier and Volume targets in people with Very Preterm Infant and Very Low Birthweight, run by Harvard School of Public Health (HSPH) at 4 sites in India.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 21 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in India. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ilana Dzuba, MHS (617-384-6555, idzuba@ariadnelabs.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Length-for-age Z score (LAZ) (time frame: 3 Months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Jan 2026.