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

Skin-to-skin combined with breastfeeding shortened the cycle of full-oral feeding in premature infants

Study Overview

• Status: Completed
• Conditions: Premature
• Intervention / Treatment: Behavioral: Early skin-to-skin combined with breast-feeding

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 Type: Interventional
• Enrollment (Actual): 148
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Shanghai, China
    • Children's Hospital of Fudan University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: No older than 3 days (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: standard group; Feeding procedures follow clinical nursing practices
Experimental: intervention group; At appropriate time to invite mothers of premature infants into the NICU for skin-to-skin and breastfeeding	Behavioral: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	During the hospitalization, an average of 2 to 3 months

Collaborators and Investigators

• Sponsor: Children's Hospital of Fudan University
• Investigators: Study Chair: ling li Li, Wanyuan Road 399,Minhang District, Shanghai,China

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): April 8, 2020
• Primary Completion (Actual): May 1, 2022
• Study Completion (Actual): May 30, 2022

Study Registration Dates

• First Submitted: February 18, 2020
• First Submitted That Met QC Criteria: February 23, 2020
• First Posted (Actual): February 25, 2020

Study Record Updates

• Last Update Posted (Estimate): December 8, 2022
• Last Update Submitted That Met QC Criteria: December 6, 2022
• Last Verified: December 1, 2022

More Information

Terms related to this study

• Keywords: oral feeding; premature; Skin Contact; bresatfeeding
• Additional Relevant MeSH Terms: Pregnancy Complications; Obstetric Labor Complications; Obstetric Labor, Premature; Premature Birth
• Other Study ID Numbers: EKYY-2019-295

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No