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

• Register: ISRCTN
• Last refreshed on: 29 November 2021
• Main ID: ISRCTN95873364
• Date of registration: 08/04/2016
• Prospective Registration: No
• Primary sponsor: Paediatric Academic Clinical Program
• Public title: Safety of the varying concentrations of milk feeds with food additives and medications
• Scientific title: Medications increasing osmolality and compromising the safety of enteral feeding in preterm infants
• Date of first enrolment: 20/05/2014
• Target sample size: 9
• Recruitment status: Completed
• URL: https://www.isrctn.com/ISRCTN95873364
• Study type: Observational
• Study design: Cross-sectional laboratory-based study. (Other)
• Phase: Not Applicable

Countries of recruitment

Singapore

Contacts

• Name: Suresh Chandran

Key inclusion & exclusion 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: Mothers who do not want to participate due to personal reasons.

Age minimum:
Age maximum:
Gender: Female

Health Condition(s) or Problem(s) studied

Osmolality of milk feeds
Not Applicable
Osmolality of milk feeds

Intervention(s)

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 osmolality, the frozen EBM is thawed by transferring to the fridge (4°C) for at least 12 hours. Milk osmolality of each aliquot is measured three times at baseline, following which, fortifier and/or medications are added.

Additives added to dilutents:
1. Caffeine citrate (20mg/ml)
2. Folic acid (100mcg/ml)
3. Hydrochlorothiazide (5mg/ml)
4. Omeprazole (2mg/ml)
5. Phenobarbitone (10mg/ml)
6. Sodium phosphate (phosphate 0.52mmol/ml and sodium 0.85 mmol/ml)
7. Calcium glubionate (elemental calcium 115mg/5ml)
8. Domperidone suspension (1mg/ml)
9. Ibuprofen syrup (100mg/5ml)
10. Iron polymaltose drops (1ml = 50mg)
11. Multivitamin drops
12. Potassium dihydrogen phosphate (1mmol/1ml)
13. 20% sodium chloride (Na 3.4mmol/ml)
14. Ursodeoxycholic acid suspension (250mg/5ml)

The osmolality of medications and diluents was measured neat and in a combination of each medication with each diluent via the freezing point depressing method, utilizing an Advanced Micro-osmometer Model 3300 (Advanced Instruments, Inc. Two Technology Way, Norwood, MA 02062). The highest osmolality measurable by this method is 2000 mOsm/kg.

Primary Outcome(s)

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

Secondary Outcome(s)

No secondary outcome measures

Secondary ID(s)

N/A

Source(s) of Monetary Support

Paediatric Academic Clinical Program, KK Women's and Children's Hospital

Results

• Results available: Yes
• Date Completed: 19/05/2015