Intervention Facilitates Oral Feeding in Premature Infants
Primary Purpose
Premature
Status
Completed
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Early skin-to-skin combined with breast-feeding
Sponsored by

About this trial
This is an interventional supportive care trial for Premature focused on measuring Skin Contact, bresatfeeding, premature, oral feeding
Eligibility Criteria
Inclusion Criteria:
- gestational age ≤30 weeks
- birth weight < 1500g
- age of admission <72 hours
- no congenital malformation
Exclusion Criteria:
- OI > 40
- mother has trouble in communicating
Sites / Locations
- Children's Hospital of Fudan University
Arms of the Study
Arm 1
Arm 2
Arm Type
No Intervention
Experimental
Arm Label
standard group
intervention group
Arm Description
Feeding procedures follow clinical nursing practices
At appropriate time to invite mothers of premature infants into the NICU for skin-to-skin and breastfeeding
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Exclusive breastfeeding at discharge
Exclusive breastfeeding at discharge is defined as through breastfeeding without bottle feeding at discharge.On the day of discharge, newborns are weighed before regular feeding and then breastfed by their mothers. After breastfeeding, the baby is weighed again and the amount of breast milk obtained by sucking the mother's breast is assessed. If the two weight subtractions are greater than or equal to the amount required for once bottle feeding, the baby is considered exclusively breastfeding at discharge.
Full Information
NCT ID
NCT04283682
First Posted
February 18, 2020
Last Updated
December 6, 2022
Sponsor
Children's Hospital of Fudan University
1. Study Identification
Unique Protocol Identification Number
NCT04283682
Brief Title
Intervention Facilitates Oral Feeding in Premature Infants
Official Title
The Effect of Early Skin Contact Combined With Breastfeeding on Oral Feeding in Premature Infants ≤30 Weeks of Gestation
Study Type
Interventional
2. Study Status
Record Verification Date
December 2022
Overall Recruitment Status
Completed
Study Start Date
April 8, 2020 (Actual)
Primary Completion Date
May 1, 2022 (Actual)
Study Completion Date
May 30, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Children's Hospital of Fudan University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
Skin-to-skin combined with breastfeeding shortened the cycle of full-oral feeding in premature infants
Detailed Description
This study is conducted at the level 3 NICU of the Children's Hospital of Fudan University, Shanghai, People's Republic of China, a tertiary medical center. Infants admitted to the NICU are all outborn infants.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Premature
Keywords
Skin Contact, bresatfeeding, premature, oral feeding
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
148 (Actual)
8. Arms, Groups, and Interventions
Arm Title
standard group
Arm Type
No Intervention
Arm Description
Feeding procedures follow clinical nursing practices
Arm Title
intervention group
Arm Type
Experimental
Arm Description
At appropriate time to invite mothers of premature infants into the NICU for skin-to-skin and breastfeeding
Intervention Type
Behavioral
Intervention Name(s)
Early skin-to-skin combined with breast-feeding
Intervention Description
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.
Primary Outcome Measure Information:
Title
Transition time from the initiation oral feeding to full oral feeding
Description
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.
Time Frame
During the procedure
Secondary Outcome Measure Information:
Title
Exclusive breastfeeding at discharge
Description
Exclusive breastfeeding at discharge is defined as through breastfeeding without bottle feeding at discharge.On the day of discharge, newborns are weighed before regular feeding and then breastfed by their mothers. After breastfeeding, the baby is weighed again and the amount of breast milk obtained by sucking the mother's breast is assessed. If the two weight subtractions are greater than or equal to the amount required for once bottle feeding, the baby is considered exclusively breastfeding at discharge.
Time Frame
During the hospitalization, an average of 2 to 3 months
10. Eligibility
Sex
All
Maximum Age & Unit of Time
72 Hours
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
gestational age ≤30 weeks
birth weight < 1500g
age of admission <72 hours
no congenital malformation
Exclusion Criteria:
OI > 40
mother has trouble in communicating
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
ling li Li
Organizational Affiliation
Wanyuan Road 399,Minhang District, Shanghai,China
Official's Role
Study Chair
Facility Information:
Facility Name
Children's Hospital of Fudan University
City
Shanghai
Country
China
12. IPD Sharing Statement
Citations:
PubMed Identifier
34535164
Citation
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.
Results Reference
derived
Learn more about this trial
Intervention Facilitates Oral Feeding in Premature Infants
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