Intervention Facilitates Oral Feeding in Premature Infants

Not Applicable

Completed

• Conditions: Premature
• Interventions: Behavioral: Early skin-to-skin combined with breast-feeding

• Registration Number: NCT04283682
• Lead Sponsor: Children's Hospital of Fudan University

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.

Study Timeline

• Study First Submitted: 2020-02-18
• Study First Submitted QC: 2020-02-23
• Study First Posted: 2020-02-25
• Study Start: 2020-04-08
• Primary Completion: 2022-05-01
• Study Completion: 2022-05-30
• Status Verified: 2022-12
• Last Update Submitted: 2022-12-06
• Last Update Posted: 2022-12-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 148

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
intervention group	Early skin-to-skin combined with breast-feeding	At appropriate time to invite mothers of premature infants into the NICU for skin-to-skin and breastfeeding

Primary Outcome Measures

Name	Time	Method
Transition time from the initiation oral feeding to full oral feeding	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 Outcome Measures

Name	Time	Method
Exclusive breastfeeding at discharge	During the hospitalization, an average of 2 to 3 months	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.

Trial Locations

Locations (1)

Children's Hospital of Fudan University; 🇨🇳 Shanghai, China