Safety of the varying concentrations of milk feeds with food additives and medications

Medications increasing osmolality and compromising the safety of enteral feeding in preterm infants

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

ISRCTN

Registry ID

ISRCTN95873364

Enrollment

Registered

2016-04-08

Start date

2014-05-20

Completion date

Unknown

Last updated

2021-11-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Osmolality of milk feeds Not Applicable Osmolality of milk feeds

Interventions

Participants donate 60-80ml breast milk, which is collected using a breast pump. Pooled expressed breast milk (EBM) is stored in aliquots and is frozen at –5°C to –15°C. Before measuring the osmolalit

Eligibility

Sex/Gender

Female

Inclusion criteria

Inclusion criteria: 1. Aged 28 to 41 years 2. Delivered their infants preterm (<37 weeks of gestation) 3. Willing to donate their breast milk

Exclusion criteria

Exclusion criteria: Mothers who do not want to participate due to personal reasons.

Design outcomes

Primary

Measure	Time frame
Osmolality of expressed breast milk is measured using osmometer at baseline, when additives are added and 4 hours after additives are added.	—

Secondary

Measure	Time frame
No secondary outcome measures	—

Countries

Singapore

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026