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OpenTrials
Completed

NCT Number: NCT05256927

Is Milk Associated with Glycemia in the NICU

The purpose of this study is to determine if concentrations of hormones in prepared human milk (HM) feeds are associated with metabolic disturbances in the recipient premature infant. To do so, prospectively 100 infants receiving HM-derived fortifiers as part of clinical care will be studied, saving aliquots of daily prepared feeds until any fortification ceases.

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Key information

Age range

0 day–3 month

Sex eligibility

All sexes

Study type

Observational

Primary location

University of Rochester Medical Center

Rochester, New York, 14642, United States

About this study

The purpose of this study is to determine if concentrations of these hormones in prepared HM feeds are associated with metabolic disturbances in the recipient infant. A prospectively study 100 infants receiving HM-derived fortifiers as part of clinical care, saving aliquots of daily prepared feeds until any fortification ceases. Insulin and PTHrP will be compared in feeds from matched days when metabolic disturbances were documented vs not; each infant serving as a control.

Hypothesis 1 Feed dose of insulin and PTHrP will be higher from days when hypoglycemia and hypercalcemia are observed, respectively, vs control days when metabolic disturbances are not observed.

Hypothesis 2: Over time, daily feed dose of insulin will correlate with average daily blood glucose in infants receiving HM products.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Infants eligible to receive human milk (HM)-derived fortifiers. To qualify for these fortifiers, infants must be born <30 weeks gestation and/or weigh <1250g at birth. Enteral or oral feeding modes both qualify for participation. Additional supplementation to feeds beyond HM-derived fortifier (such as medium-chain triglycerides) is acceptable.
  • Infants initially on intravenous nutrition will still be eligible for consent. Feed sample collections from these infants will commence once they advance to consume HM-based feeds once HM-derived fortifier is prescribed.

Exclusion criteria

  • Infants diagnosed with congenital disorders that impact glucose or calcium metabolism will be excluded.
  • Infants with conditions necessitating specialized diets (ex: chylothorax) will also be excluded.
  • Non-English speaking subjects will be excluded as the team of study personnel includes those that speak English only.

Treatment and study plan

Primary outcomes

  1. Insulin concentration in prepared feeds

    Time frame: 3 months

    We will measure final insulin concentrations in enteral feed preparations that contain some portion of human milk.

  2. Parathyroid hormone related protein (PTHrP) concentration in prepared feeds

    Time frame: 3 months

    We will measure final PTHrP concentrations in enteral feed preparations that contain some portion of human milk.

Sponsors and collaborators

Lead sponsor

University of Rochester

Other

Collaborators

  • National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Registry information

Official study title

Is Milk Associated with Glycemia in the NICU (MAGIC) a Study in the NICU

Acronym: MAGIC

Important dates

Study start
2022
Primary completion
2024
Study completion
2024
First posted
Feb 25, 2022
Registry last updated
Mar 10, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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