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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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04283682
Enrollment
148
Registered
2020-02-25
Start date
2020-04-08
Completion date
2022-05-30
Last updated
2022-12-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Premature

Keywords

Skin Contact, bresatfeeding, premature, oral feeding

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.

Interventions

BEHAVIORALEarly 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.

Sponsors

Children's Hospital of Fudan University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
No minimum to 72 Hours
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Transition time from the initiation oral feeding to full oral feedingDuring the procedureTransition 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

MeasureTime frameDescription
Exclusive breastfeeding at dischargeDuring the hospitalization, an average of 2 to 3 monthsExclusive 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.

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 21, 2026