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

ISRCTN ISRCTN95873364
DOI https://doi.org/10.1186/ISRCTN95873364
Secondary identifying numbers N/A
Submission date
29/03/2016
Registration date
08/04/2016
Last edited
18/11/2021
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Other
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data

Plain English summary of protocol

Background and study aims
Breastfeeding has been shown to be beneficial for babies, helping to protect them against diseases and providing all the nutrition they need for healthy growth. It is well known that certain substances can be passed from the mother to the baby via breast milk. If a mother has to take a medication, the medication is sometimes diluted with water, but studies have shown that this can raise the osmolality of breast milk, which can cause complications in the baby. Osmolality is the amount of a substance dissolved in a liquid. The aim of this study is to compare the changes in osmolality of 14 medications and other substances in breast milk.

Who can participate?
Women aged 28 to 41 who have delivered their baby at least three weeks early.

What does the study involve?
Women provide a sample of 60-80ml breast milk, expressed using a breast pump. The samples then have their osmolality (concentration) tested before a medication or fortifier is added. The osmolality is tested using a specialised machine called an osmometer. After the medication/fortifier has been added to the breast milk, the osmolality is then retested. This is then repeated four hours later.

What are the possible benefits and risks of participating?
There are no direct benefits or risks for participants taking part in this study.

Where is the study run from?
KK Women's and Children's Hospital (Singapore)

When is the study starting and how long is it expected to run for?
May 2014 to May 2015

Who is funding the study?
Paediatric Academic Clinical Program, KK Women’s and Children’s Hospital (Singapore)

Who is the main contact?
Dr Suresh Chandran

Contact information

Dr Suresh Chandran
Scientific

KK Womens and Childrens Hospital
Department Of Neonatology
100 Bukit Timah Road
-
229899
Singapore

Study information

Study designCross-sectional laboratory-based study.
Primary study designObservational
Secondary study designCross sectional study
Study setting(s)Hospital
Study typeOther
Participant information sheet Not available in web format, please use the contact details below to request a patient information sheet.
Scientific titleMedications increasing osmolality and compromising the safety of enteral feeding in preterm infants
Study objectivesHypothesis
The addition of commonly used medications to oral neonatal feeds increase the osmolality beyond that of the safety range as determined by the American Academy of Paediatrics (AAP).

Specific study aims:
1. To determine the osmolality of 15 commonly used medications prescribed in neonates
2. To determine the appropriate type and amount of diluent necessary to ensure osmolality of oral feeds remains within the safety range after the addition of medications
3. To evaluate the changes in osmolality of the medications in expressed breast milk and preterm formula after the addition of these 15 commonly used medications in neonatal care respectively and to explore if there is a correlation between osmolality and the amount of diluent added
4. To determine the changes of osmolality of expressed breast milk and preterm formula with time when medications are added
Ethics approval(s)Sing Health Centralised Institutional Review Board, 20/05/2014, ref: 2014/308/E
Health condition(s) or problem(s) studiedOsmolality of milk feeds
InterventionParticipants 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.
Intervention typeOther
Primary outcome measureOsmolality of expressed breast milk is measured using osmometer at baseline, when additives are added and 4 hours after additives are added.
Secondary outcome measuresNo secondary outcome measures
Overall study start date20/05/2014
Completion date19/05/2015

Eligibility

Participant type(s)Other
Age groupOther
SexFemale
Target number of participantsNine mothers who volunterely donated breast milk
Key inclusion criteria1. Aged 28 to 41 years
2. Delivered their infants preterm (<37 weeks of gestation)
3. Willing to donate their breast milk
Key exclusion criteriaMothers who do not want to participate due to personal reasons.
Date of first enrolment20/05/2014
Date of final enrolment31/08/2014

Locations

Countries of recruitment

  • Singapore

Study participating centre

KK Women's and Children's Hospital
100 Bukit Timah Road
-
229899
Singapore

Sponsor information

Paediatric Academic Clinical Program
Research organisation

KK Womens and Childrens Hospital
100 Bukit Timah Road
-
229899
Singapore

ROR logo "ROR" https://ror.org/01tgyzw49

Funders

Funder type

Research organisation

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

No information available

Results and Publications

Intention to publish date31/12/2016
Individual participant data (IPD) Intention to shareYes
IPD sharing plan summaryOther
Publication and dissemination plan1. Poster presentation done at the Evidence based Neonatology Conference held in Philadelphia, USA - Sept 2015
2. Planned publication of study results within 3-6 months in a peer reviewed journal
IPD sharing planNot provided at time of registration

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Results article 29/12/2016 18/11/2021 Yes No

Editorial Notes

18/11/2021: Publication reference added.