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New treatment option for Very Preterm Infant
Official title LIFT-UP: Randomized Controlled Trial of Fortification of Human Milk
ClinicalTrials.gov ID: NCT06765863
What this study is testing
- What it's testing
- 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?
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages up to 48. Healthy volunteers may be eligible.
You may be able to join if
- 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...
- 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
You likely can't join if
- Lives outside the defined catchment area
- Congenital abnormalities or acquired conditions that interfere with feeding or placement of nasogastric/orogastric tube [cleft lip/palate...
- Severe birth asphyxia
- Critically ill (i.e. not on enteral feeds)
- Unknown date of birth and unknown gestational age
See the full eligibility criteria
- 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\ \ \
- 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)...
- Severe birth asphyxia
- Critically ill (i.e. not on enteral feeds)
- Unknown date of birth and unknown gestational age
The study team makes the final eligibility decision.
Where it's taking place
- Ballary, Karnataka, India
- Belagavi, Karnataka, India
- Davangere, Karnataka, India
- Hyderabad, Telangana, India
Compensation & support
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, up to 48 hours. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Ballary, Karnataka, India; Belagavi, Karnataka, India; Davangere, Karnataka, India; Hyderabad, Telangana, India. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.