None listed
Conditions
Brief summary
This study aims to investigate the development of preterm breastfeeding skills and the impact of bottle-feeding teats, nipple shields and degree of breast fullness on the achievement of full oral feeding. As mothers are unable to be in the neonatal nursery for all of their infant’s suck feeds, bottle feeds are required occasionally. There is evidence that an intraoral vacuum-triggered teat (Calmita, Medela AG) encourages a sucking action similar to breastfeeding and reduces the length of hospital stay and formula use at discharge compared to a conventional teat. We wish to examine the effects of different teats and breastfeeding support on feeding outcomes. Objectives: 1. To track over time the maturation of intraoral vacuum, coordination of sucking, swallowing and breathing, and maintenance of a normal heart rate and oxygen saturation during feeding, and to determine if this is related to increased breastfeeding effectiveness and efficiency. 2. To explore the effect of the amount of milk available in the breast on the volume of milk transferred during breastfeeding at 34 weeks corrected gestational age (CGA). 3. To explore the use of a nipple shield on the volume of milk transferred at 35 weeks CGA. 4. To compare suck-swallow-breathe coordination during breastfeeding with that during bottle feeding with Calmita, and bottle-feeding with a conventional teat. 5. To determine the effect of a vacuum triggered teat on timing of achievement of full breastfeeding and on breastfeeding duration
Interventions
For oral feeds where the breastfeeding mother is not available, bottle feeds will be offered using differing bottle-feeding teats according to infant allocation.
Experimental group: a vacuum triggered bottle-feeding teat (Calmita starter or advanced, Medela AG) will be used throughout the infant’s stay in the study site’s neonatal nurseries. Experimental group infants will use the Calmita starter teat (lower vacuum threshold), and will change to the advanced teat (higher vacuum threshold) upon d
For oral feeds where the breastfeeding mother is not available, bottle feeds will be offered using differing bottle-feeding teats according to infant allocation. Experimental group: a vacuum triggered bottle-feeding teat (Calmita starter or advanced, Medela AG) will be used throughout the infant’s stay in the study site’s neonatal nurseries. Experimental group infants will use the Calmita starter teat (lower vacuum threshold), and will change to the advanced teat (higher vacuum threshold) upon demonstrating the ability to suck a full feed with the starter teat. Adherence to use of the experimental teat will be monitored by research and nominated clinical staff on at least 4 days per week.
Sponsors
Centre for Neonatal Research and Education, The University of Western Australia
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Investigator)
Eligibility
Sex/Gender
All
Age
No minimum to 4 Weeks
Healthy volunteers
No
Inclusion criteria
Medically stable preterm infants born 24 – 33 weeks, and mothers with an intention to breastfeed that have a total daily breastmilk expression volume of at least 300 mL/24hr.
Exclusion criteria
Mothers with a history of breast surgery, infants receiving CPAP or mechanical ventilation at 34 weeks CGA, acute illness and/or infection and congenital disease or malformation.
Outcome results
None listed