An interventional study of Early skin-to-skin combined with breast-feeding in Premature, sponsored by Children's Hospital of Fudan University. Completed at 1 site in China. Open to participants aged Up to 72 Hours. Per ClinicalTrials.gov, last updated 2022-12-08.
Sponsored by Children's Hospital of Fudan University · Not applicable, Interventional, and Supportive care
Skin-to-skin combined with breastfeeding shortened the cycle of full-oral feeding in premature infants
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.
2,553 studies on the registry are indexed under Premature Birth; 498 are open to participants now.
This study's enrollment of 148 is above the median of 84 across 1,688 interventional studies indexed under Premature Birth.
Browse Premature Birth studies →Children's Hospital of Fudan University is the lead sponsor of 262 studies on the registry; 92 are open to participants now.
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Exclusion Criteria:
Feeding procedures follow clinical nursing practices
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.
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.
Time frame: During the procedure
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.
Time frame: During the hospitalization, an average of 2 to 3 months
This study is completed, as verified in Dec 2022. You cannot join it, but the record below documents what was studied.
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Children's Hospital of Fudan University