Intervention Facilitates Oral Feeding in Premature Infants
NCT ID: NCT04283682
Last Updated: 2022-12-08
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
148 participants
INTERVENTIONAL
2020-04-08
2022-05-30
Brief Summary
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Detailed Description
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The study is approved by the Ethics Committee of the Children's Hospital of Fudan University. Signed parental consent is obtained before participants'entry into the study. The RCT is conducted to evaluate the effectiveness of skin-to-skin combined with breastfeeding reduce the transition time from tube feeding to independent oral feeding.
The recruited infants are assigned to intervention group and control group.
Data are presented as means ± sds for continuous variables with normal distribution and percentages (%) for categorical variables. One-way analysis of variance and Fisher exact test is used to compare infants' baseline characteristics among the two groups. All statistical analyses are conducted using SPSS. A p value of less than 0.05 is regarded as statistically significant.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
NONE
Study Groups
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standard group
Feeding procedures follow clinical nursing practices
No interventions assigned to this group
intervention group
At appropriate time to invite mothers of premature infants into the NICU for skin-to-skin and breastfeeding
Early skin-to-skin combined with breast-feeding
Premature infants in the intervention group have access to skin-to-skin once a day for 1 hour at least once no ventilation support needed. During the skin-to-skin period,the breastfeeding is encouraged for about 5-10 minutes. The whole intervention stop until the baby achieve the full oral feeding.
Interventions
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Early skin-to-skin combined with breast-feeding
Premature infants in the intervention group have access to skin-to-skin once a day for 1 hour at least once no ventilation support needed. During the skin-to-skin period,the breastfeeding is encouraged for about 5-10 minutes. The whole intervention stop until the baby achieve the full oral feeding.
Eligibility Criteria
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Inclusion Criteria
* birth weight \< 1500g
* age of admission \<72 hours
* no congenital malformation
Exclusion Criteria
* mother has trouble in communicating
72 Hours
ALL
No
Sponsors
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Children's Hospital of Fudan University
OTHER
Responsible Party
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Principal Investigators
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ling li Li
Role: STUDY_CHAIR
Wanyuan Road 399,Minhang District, Shanghai,China
Locations
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Children's Hospital of Fudan University
Shanghai, , China
Countries
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References
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Li L, Wang L, Niu C, Liu C, Lv T, Ji F, Yu L, Yan W, Dou YL, Wang Y, Cao Y, Huang G, Hu X. 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. Trials. 2021 Sep 17;22(1):637. doi: 10.1186/s13063-021-05605-x.
Other Identifiers
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EKYY-2019-295
Identifier Type: -
Identifier Source: org_study_id
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