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Intervention Facilitates Oral Feeding in Premature Infants

Fudan University logo

Fudan University

Status

Completed

Conditions

Premature

Treatments

Behavioral: Early skin-to-skin combined with breast-feeding

Study type

Interventional

Funder types

Other

Identifiers

NCT04283682
EKYY-2019-295

Details and patient eligibility

About

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

Full 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.

Enrollment

148 patients

Sex

All

Ages

Under 72 hours old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Supportive Care

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

148 participants in 2 patient groups

standard group
No Intervention group
Description:
Feeding procedures follow clinical nursing practices
intervention group
Experimental group
Description:
At appropriate time to invite mothers of premature infants into the NICU for skin-to-skin and breastfeeding
Treatment:
Behavioral: Early skin-to-skin combined with breast-feeding

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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