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Clinical Trials/NCT04283682
NCT04283682
Completed
N/A

The Effect of Early Skin Contact Combined With Breastfeeding on Oral Feeding in Premature Infants ≤30 Weeks of Gestation

Children's Hospital of Fudan University1 site in 1 country148 target enrollmentApril 8, 2020
ConditionsPremature

Overview

Phase
N/A
Intervention
Not specified
Conditions
Premature
Sponsor
Children's Hospital of Fudan University
Enrollment
148
Locations
1
Primary Endpoint
Transition time from the initiation oral feeding to full oral feeding
Status
Completed
Last Updated
3 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
April 8, 2020
End Date
May 30, 2022
Last Updated
3 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • gestational age ≤30 weeks
  • birth weight \< 1500g
  • age of admission \<72 hours
  • no congenital malformation

Exclusion Criteria

  • mother has trouble in communicating

Outcomes

Primary Outcomes

Transition time from the initiation oral feeding to full oral feeding

Time Frame: During the procedure

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 Outcomes

  • Exclusive breastfeeding at discharge(During the hospitalization, an average of 2 to 3 months)

Study Sites (1)

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