ArticleTrials2021
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.
Article in Trials, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 2 registered trials, which are not on this map. Cited by 8 papers.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
The Effect of Early Skin Contact Combined With Breastfeeding on Oral Feeding in Premature Infants ≤30 Weeks of Gestation
The Effect of usıng Breast mılk pacıfıer, Sucrose pacıfıer and pacıfıer ın reducıng the paın That Occurs durıng orogastrıc Tube ınsertıon ın Preterm Newborns
Who cites it
8 citing papers in PubMed.
- Pacifier use in preterm infants during orogastric tube feeding: a randomized trial.Revista da Associacao Medica Brasileira (1992) · 2026Trial
- Outcomes of Clinically Stable 34-Week Preterm Infants Managed in Rooming-In Versus Neonatal Unit Admission.Acta paediatrica (Oslo, Norway : 1992) · 2026Observational
- Article
- Effect of oromotor stimulation on early sucking behavior and later development in preterm newborns.Bioinformation · 2025Article
- Multisensory stimulation and its effect on breast milk volume production in mothers of premature infants.Frontiers in pediatrics · 2024Article
- Article
- Influence of Full Oral Feeding Acquisition on Growth of Premature Infants.Frontiers in pediatrics · 2022Article
- Oral feeding skills in premature infants: A concept analysis.Belitung nursing journal · 2022Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
13 authors.
Funding
Abstract
backgroundMost 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.
methodsThis 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 registrationClinicalTrials.gov NCT04283682. Registered on 8 February 2020.
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Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.