ABSTRACT
BACKGROUND: Neonatal jaundice is a common condition occurring in 60%-80% of all healthy-term and late-preterm neonates. In the majority of cases, neonatal jaundice resolves spontaneously and causes no harm; however, in some neonates, signiï¬cant hyperbilirubinemia can develop and lead to kernicterus jaundice, a serious neurological disease. Phototherapy (PT) is the preferred treatment for jaundice; however, to be effective, PT devices need to have a broad light emission surface to generate no or little heat and to provide an optimal wavelength and light intensity (420-490 nm and ≥30 µW/cm²/nm, respectively). OBJECTIVE: This study aimed to investigate the feasibility, safety, and level of satisfaction of parents and health care teams with the BUBOlight device, an innovative alternative to conventional hospital PT, in which luminous textiles have been incorporated in a sleeping bag. METHODS: This interventional, exploratory, simple group, nonrandomized, single-center trial will be conducted at Lille Hospital. In total, 10-15 neonates and their parents will be included to obtain evaluable data from 10 parent-neonate pairs. Neonates weighing more than 2500 g at birth and born with ≥37 weeks of amenorrhea that required PT in accordance with the guidelines of the National Institute For Health and Clinical Excellence will receive one 4-hour session of illumination. Total serum bilirubin and transcutaneous bilirubin levels were obtained at the start and 2 hours after the end of PT. Cutaneous and rectal temperatures, heart rate, and oxygen saturation will be measured at the beginning and during PT. The number of subjects is therefore not calculated on the basis of statistical assumptions. We aim to obtain a minimum proportion of 90% (ie, 9 of 10) of the neonates included, who have been able to undergo 4-hour PT without unacceptable and unexpected toxicities. We will calculate the mean, median, quartiles, minimum and maximum values of the quantitative parameters, and the frequency of the qualitative parameters. The rate of patients with no unacceptable and unexpected toxicities (ie, the primary endpoint) will be calculated. RESULTS: The first patient is expected to be enrolled at the end of 2020, and clinical investigations are intended for up to June 2021. The final results of this study are expected to be available at the end of 2021. CONCLUSIONS: Our findings will provide insights into the safety and feasibility of a new PT device based on light-emitting fabrics for the treatment of newborn jaundice. This new system, if proven effective, will improve the humanization of neonatal care and help avoid mother-child separation. TRIAL REGISTRATION: ClinicalTrials.gov NCT04365998; https://clinicaltrials.gov/ct2/show/NCT04365998. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): PRR1-10.2196/24808.
ABSTRACT
OBJECTIVE: Caesarean section is a well-known cause of difficulties in breastfeeding initiation. Mother-infant skin-to-skin contact allows to improve breastfeeding and maternal comfort but remains few practiced during caesarean section. Our objective was to evaluate maternal comfort before and after immediate skin-to-skin contact in case of elective caesarean section. METHODS: This was a prospective, observational, monocenter study including patients with elective caesarean section. Mother-infant skin-to-skin contact was begun immediately after birth. The Analgesia Nociception Index (ANI) is a well know heart rate variability (HRV) index, currently used in anesthesia, which decreases during painful stimulation and increases with maternal comfort. The Analgesia Nociception Index was compared before and after skin-to-skin contact. RESULTS: 53 patients were included. Skin-to-skin contact was started on average 4min (2-14, IIQ (3-5)) after birth. The median duration was 21min (4-40, IIQ (12.3-29.5)). It was interrupted in 24 patients: 9 from mother's wish, 11 for maternal reasons (drowsiness, stress, pain, maternal hypothermia, lipothymia, vertigo, nausea, cough) and 4 for the newborn (respiratory distress, low pH). The median Analgesia Nociception Index at the end of skin-to-skin contact and at the end of the intervention was statistically higher than that before skin-to-skin contact (p=0.034 and p<10-3 respectively). CONCLUSION: Skin-to-skin contact is possible during caesarean section and allows a better maternal comfort. It should be encouraged and proposed to patients during elective caesarean section. It will be interesting to evaluate it in case of caesarean section during labor.
