Intervention Facilitates Oral Feeding in Premature Infants
The Effect of Early Skin Contact Combined With Breastfeeding on Oral Feeding in Premature Infants ≤30 Weeks of Gestation
1 other identifier
interventional
148
1 country
1
Brief Summary
Skin-to-skin combined with breastfeeding shortened the cycle of full-oral feeding in premature infants
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Apr 2020
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 18, 2020
CompletedFirst Posted
Study publicly available on registry
February 25, 2020
CompletedStudy Start
First participant enrolled
April 8, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
May 30, 2022
CompletedDecember 8, 2022
December 1, 2022
2.1 years
February 18, 2020
December 6, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Transition time from the initiation oral feeding to full oral feeding
Transition time was defined as the days needed from introduction of oral feeding to obtain autonomous oral feeding when the nasogastric tube was removed and all the daily milk volume was taken from the bottle.
During the procedure
Secondary Outcomes (1)
Exclusive breastfeeding at discharge
During the hospitalization, an average of 2 to 3 months
Study Arms (2)
standard group
NO INTERVENTIONFeeding procedures follow clinical nursing practices
intervention group
EXPERIMENTALAt appropriate time to invite mothers of premature infants into the NICU for skin-to-skin and breastfeeding
Interventions
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
You may qualify if:
- gestational age ≤30 weeks
- birth weight \< 1500g
- age of admission \<72 hours
- no congenital malformation
You may not qualify if:
- OI \> 40
- mother has trouble in communicating
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Children's Hospital of Fudan University
Shanghai, China
Related Publications (1)
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.
PMID: 34535164DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
ling li Li
Wanyuan Road 399,Minhang District, Shanghai,China
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 18, 2020
First Posted
February 25, 2020
Study Start
April 8, 2020
Primary Completion
May 1, 2022
Study Completion
May 30, 2022
Last Updated
December 8, 2022
Record last verified: 2022-12