Intervention Facilitates Oral Feeding in Premature Infants

Premature Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04283682
• Other study ID #: EKYY-2019-295
• Status: Completed
• Phase: N/A
• Start date: April 8, 2020
• Est. completion date: May 30, 2022

Study information

• Verified date: December 2022
• Source: Children's Hospital of Fudan University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 148
• Est. completion date: May 30, 2022
• Est. primary completion date: May 1, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 72 Hours

Eligibility

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

Related Conditions & MeSH terms

• Premature
• Premature Birth

Intervention

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.

Locations

Country	Name	City	State
China	Children's Hospital of Fudan University	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Children's Hospital of Fudan University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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