Early skin contact combined with mother’s breastfeeding to shorten the process of premature infants ≤ 30 weeks of gestation to achieve full oral feeding: the study protocol of a randomized controlled trial

Abstract

Background Most hospitalized preterm infants experience difficulties in transitioning from tube feeding to full oral feeding. Interventions to promote full oral feeding in preterm infants in the neonatal intensive care unit (NICU) are limited to pacifier use or bottle-feeding exercises. Skin contact has been shown to be beneficial to start and maintain lactation and provide preterm infants with the opportunity to suck on the mother’s breast, which may promote further development of the preterm infant’s suckling patterns. The objective of this study is to compare and evaluate the effects of skin contact combined with breastfeeding (suck on the mother’s empty breast) as compared to the routine pacifier suckling training model in achieving full oral feeding for infants whose gestational age are ≤ 30 weeks. Methods This is a single-center, randomized controlled clinical trial conducted in the NICU and designed according to the SPIRIT Statement. The subjects included in the study are premature infants born between April 2020 and July 2021 with a gestational age of ≤30 weeks, birth weight of <1500 g, admission age of <72 h, and absence of congenital malformations. Those with oxygenation indices of >40 and those born to mothers with poor verbal communication skills will be excluded. A sample of 148 infants is needed. The infants will be randomized to the intervention (skin contact combined with mother’s breastfeeding model) or control group (routine pacifier sucking training model). The primary outcome is the time required to achieve full oral feeding. The secondary outcomes are the breastfeeding abilities of preterm infants as assessed by the Preterm Infant Breastfeeding Behavior Scale (PIBBS), breastfeeding rates at 3 and 6 months corrected gestational age, complication rates, duration of oxygen requirement, days of hospital stay, and satisfaction of parents. Discussion This paper describes the first single-center, open-label, randomized clinical trial on this topic and will provide crucial information to support the implementation of skin contact combined with the breastfeeding model in the NICU setting. Trial registration ClinicalTrials.gov NCT 04283682. Registered on 8 February 2020.

Influence of Full Oral Feeding Acquisition on Growth of Premature Infants

“…In our results, full oral intake occurred at a median PMA of 36.6 (33.7–43.1) weeks. These results are similar to those reported by Khan et al ( 12 ) in which they found full oral feeding skills were reached at 37.1 (35.6–38.4) weeks in extremely preterm infants and at 34.7 (34.3–35.6) weeks in very preterm infants ( p < 0.001) Kangaroo mother care was promoted in our study, ( 13 ) but other interventions that could further improve oral capabilities were not applied, such as prefeeding oral stimulation and the use of a checklist, as described by da Rosa Pereira et al ( 14 ).…”

“…These results are similar to those reported by Khan et al (12) in which they found full oral feeding skills were reached at 37. 1 (35.6-38.4) Kangaroo mother care was promoted in our study, (13) but other interventions that could further improve oral capabilities were not applied, such as prefeeding oral stimulation and the use of a checklist, as described by da Rosa Pereira et al (14).…”

Multisensory stimulation and its effect on breast milk volume production in mothers of premature infants

“…Due to the hospital's COVID-19 protocol, postpartum mothers with preterm infants in the NICU were not able to perform skin-to-skin contact (kangaroo method). The absence or delay of this method is considered to be a risk factor for the successful establishment of exclusive breastfeeding at discharge ( 54 – 56 ). Therefore, it would be essential to implement the multisensory stimuli proposed in this study with mothers who use the kangaroo method, in order to evaluate its impact on mother's own milk production.…”

Promoting Survival and Primitive Reflexes to Prevent Brain Imbalance in Premature Infants: A Scoping Review of New Insights by Physiotherapists on Developmental Disorders

“…Usually, we provide oro-motor stimulation to develop sucking [ 7 ]. Along with this, we need to promote a motherly environment in the baby’s surroundings to ensure the overall development of the premature [ 8 , 9 ]. This can be done by providing a warm, dim light environment, putting a piece of mother’s cloth in the vicinity for a sense of comfort, and making voice recordings of the mother, as this is what the baby is next to in the womb.…”