Investigation of teats to support Successful transition to Oral Feeding (SOFTT) in preterm and fragile infants (SOFTT).

Sepal Teat [Sepal Infant Feeding System] The SOFTT will use a randomized controlled cross-over design to investigate infant feeding performance, and is a single centre trial. As part of the trial design, all infants will receive bottle feeds from both types of teat. The teat allocation envelope is opened at the beside immediately prior to the commencement of the first bottle feeding trial by the infant’s allocated nurse, in the presence of the parent (if in attendance) or other health professional (if parent not in attendance). The teat allocation is recorded on the infant’s SOFTT-BF1 form. Once parent/guardian written signed consent is obtained, the consent form will be given to the nursing team leader or research officer and the infant will be allocated a participant number. The infant’s feeding schedule will then be reviewed and the date/time for the first bottle feeding trial (BF1) identified. Baseline data on the infant’s ‘SOFTT-Demographic’ data collection form will be completed and then given to the nursing team leader or research officer. BF1: The teat allocation envelope is opened at the bedside immediately prior to the commencement of the first bottle feeding trial by the infant’s treating nurse, in the presence of the parent (if in attendance) or other health professional (if parent not in attendance). The teat allocation (Teat 1 – either Sepal or Medela) will then be used for the first trial. The infant’s treating nurse will observe and score the infant’s feeding readiness cues using a feeding readiness scale, and if appropriate, proceed with the bottle feeding trial using Teat 1. Either the infant’s nurse or parent will feed the infant, however the nurse will observe infant feeding performance and infant cues throughout the trial. The length of the feed will be indicated by infant tolerance and terminated according to infant cues of satiation or feeding intolerance as per standard practice. The nurse will complete the ‘SOFTT-BF1’ data collection form at the end of the feed and give to the nursing team leader or research officer. BF2: On the following day (or next bottle feed, whichever is sooner), the second bottle feed (BF2) will be conducted using the other teat brand (Teat 2 – Medela or Sepal). Again, the infant’s treating nurse will observe the infant’s feeding readiness cues, and if appropriate, proceed with the bottle feeding trial using Teat 2. Either the infant’s nurse or parent will feed the infant, however the nurse will observe infant feeding performance and infant cues throughout the trial. The length of the feed will be indicated by infant tolerance and terminated according to infant cues of satiation or feeding intolerance. The nurse will complete the ‘SOFTT-BF2’ data collection form at the end of the feed and give to the nursing team leader or research officer. Following completion of the infant’s participation in the study, the parents/nursing staff will be free to choose their preferred teat for the individual infant for further bottle feeds during their hospital stay. All nursing staff who will be feeding infants for the “Successful Oral Feeding Teat Trial” will be required to attend an education session about the study, study procedures and how to complete study forms including recording teat information and observing infant cues (specific infant feeding readiness cues, infant state cues, suck-swallow-breath coordination, feeding tolerance cues, feeding intolerance cues, and satiation cues). As part of the evaluation of this education, nursing staff will be asked to participate in nested quality activity study to evaluate the effect of the training and use of SOFTT study data collection forms on their understanding and observation of infant cues to inform their infant feeding practices.