Back to search results

Individualized Nutrition for Preterm Infant Growth and Neurodevelopment

This study is exploring new ways to provide nutrition to very preterm infants (born at or before 32 weeks) and very low birth weight infants. Currently, human milk for these infants is often supplemented with a standard fortifier. This study compares that "Standardized Fortification" to an "Adjustable Fortification" approach. The adjustable approach involves adding extra protein and/or MCT oil (a type of fat) based on the infant's needs and the specific makeup of the human milk. The goal is to see if these new approaches can improve how quickly infants gain weight, grow in length, and increase their head circumference. This study plans to enroll 150 infants and is currently unclear on its recruitment status. To join, infants must be 4 weeks old or younger, born at or before 32 weeks, and their mother must plan to provide human milk.

Study design
This is an interventional study planning to enroll 150 participants. It compares two different methods of fortifying human milk for preterm infants.
What's involved
Participants will receive nutritional interventions from enrollment until they reach term-equivalent age (40 weeks postmenstrual age) or are discharged home, whichever happens first.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed from enrollment through the end of the nutritional intervention, which is either term-equivalent age (40 weeks postmenstrual age) or discharge home.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06266455

Individualized Nutrition to Optimize Preterm Infant Growth and Neurodevelopment

Recruiting
NAUp to 4InterventionalSupportive care
Children's National Research Institute
~150 participants
Updated 2025-07-11 on ClinicalTrials.gov
What's tested:Standardized FortificationAdjustable Fortification

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Weight Gain Velocity
Measured over Study enrollment through nutritional intervention endpoint (term-equivalent age (40 weeks PMA [postmenstrual age]) or discharge home, whichever is achieved first)
+8 more outcomes measured

Conditions

Very Preterm Maturity of Infant
Very Low Birth Weight Infant

Explore related trials

Premature infantVery low birth weight infant

NCT06266455

Where you'd take part

This study runs at 1 site. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • Children's National Hospital

    Washington D.C., District of Columbiastudy coordinator listed

    Recruiting

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

Who to contact

Catherine Limperopoulos, Ph.D.
[email protected]
202-476-5293
Email the study team

Opens a ready-to-send draft in your own email app — review before sending.

Want this trial checked against your situation?

Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.

Check eligibility for this trial ~2 min · HIPAA-protected · delete anytime
Eligibility criteria

Inclusion

Birth gestational age (GA) of ≤32 weeks
Postnatal age ≤4 weeks at time of enrollment
Maternal plan to provide human milk to infant, and consent to providing donor human milk if insufficient maternal milk supply
Maternal age \> 18 years old

Exclusion

Formula feeding prior to 36 weeks PMA or discharge home (whichever achieved first), either secondary to parental preference or medical necessity
Dysmorphic features or congenital anomalies suggestive of a genetic syndrome, metabolic disorder, chromosomal abnormality, or congenital infection
Dysgenetic or major destructive brain lesions detected by head ultrasound before enrollment

What this trial measures

  • Weight Gain VelocityStudy enrollment through nutritional intervention endpoint (term-equivalent age (40 weeks PMA [postmenstrual age]) or discharge home, whichever is achieved first)

    Weight gain velocity (grams per kilogram per day)

  • Length Growth VelocityStudy enrollment through nutritional intervention endpoint (term-equivalent age (40 weeks PMA [postmenstrual age]) or discharge home, whichever is achieved first)

    Length growth velocity (centimeters per week)

  • Head Circumference Growth VelocityStudy enrollment through nutritional intervention endpoint (term-equivalent age (40 weeks PMA [postmenstrual age]) or discharge home, whichever is achieved first)

    Head circumference growth velocity (centimeters per week)

  • Total and Regional Brain VolumesTerm-equivalent age (38 to 41 weeks postmenstrual age)

    Total and regional (cortical and deep gray matter, white matter, amygdala-hippocampus, brainstem, cerebellum) brain volumes by MRI

  • Neonatal Intensive Care Unit Network Neurobehavioral Scale (NNNS)Term-equivalent age (38 to 41 weeks postmenstrual age)

    Summary scores in 13 different domains (habituation, attention, handling, self-regulation, arousal, excitability, lethargy, hypertonicity, hypotonicity, non-optimal reflex, asymmetric reflex, quality of movement, stress)

  • Mullen Scales of Early Learning (MSEL)18 months corrected age

    Composite score as well as 5 subscores: gross motor, fine motor, visual reception, receptive language, and expressive language (reported as standardized t-scores, higher score indicates a better outcome, mean standardized t-score of 50 with standard deviation of 10)

  • Mullen Scales of Early Learning (MSEL)36 months (3 years) of age

    Composite score as well as 5 subscores: gross motor, fine motor, visual reception, receptive language, and expressive language (reported as standardized t-scores, higher score indicates a better outcome, mean standardized t-score score of 50 with standard deviation of 10)

  • Wechsler Preschool and Primary Scale of Intelligence (4th edition) (WPPSI-IV)60 months (5 years) of age

    Five primary indices: verbal comprehension, visual spatial, working memory, fluid reasoning, and processing speed (higher score indicates better performance, score range 40 to 160)

  • Differential Abilities Scale (2nd edition)-(DAS-II)60 months (5 years) of age

    \*For children with significant delays who may be unable to reach basal scores on the WPPSI-IV Early years core battery: verbal, nonverbal, and spatial reasoning subtests (higher score indicates better performance, score range 40-170)