2 Clinical Trials for Various Conditions
This study is a randomized controlled trial comparing standard fortification of donor breast milk to targeted fortification of donor breast milk in preterm infants. The purpose of the study is to determine if there is a benefit to target fortifying donor breast milk in the preterm population. The investigators hypothesize that infants receiving targeted fortification of donor breast milk will have improved growth compared to infants receiving standard fortification of donor breast milk.
Currently American Academy of Pediatrics (AAP) Bright Futures Guideline recommends 2 visits for all healthy term newborn infants in the first 6 weeks of life, first at 3-5 days of life and the second at around a month. However, compliant parents of infants are known to get at least 1-2 extra visits due to primary care provider's concern about appropriate weight gain. These weight check visits as they take up extra time, car gas, parking charges, loss of work time and paying for childcare during the visits. Clinic resources are also unnecessarily utilized. Remote home monitoring of infant weights with the use of technology could reduce the need for office visits and improve efficiency on the provider side, enhance parental satisfaction and decrease transmission of viruses in the winter season. The main objective is to monitor the daily weight of term infants born at 37 completed weeks of greater, discharged from the newborn nursery, remotely through the electronic medical record by the primary care provider and to reduce any extra visit in the first six weeks of life. Using block randomization, the infants will be assigned to either group A, where no home telemonitoring of weight will take place or group B, where the parent will be provided with a weighing scale. The parent will enter the weight into the MyChart application on the smartphone or on the computer which will be tracked by the pediatrician. The pediatrician will take the decision whether to bring the infant in for a weight check visit based on the weight information. If the weight gain is satisfactory, the pediatrician will see the patient at around 1 month of age per recommendation and the parents will stop the weight checks at that time. The sample size required was 16 on each arm (total 32) which has been increased to 20 each arm to account for technical problems and/or loss to follow up.