Intervention Facilitates Oral Feeding in Premature Infants

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

Detailed Description
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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.

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

Conditions
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Premature

Intervention / Treatment
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* Behavioral: Early skin-to-skin combined with breast-feeding


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Maximum Age: 72 Hours

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: standard group<br>Feeding procedures follow clinical nursing practices | |
| Experimental: intervention group<br>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<br>* 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.<br>|

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Skin Contact, bresatfeeding, premature, oral feeding