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. 2021 Apr 26;22(1):304.
doi: 10.1186/s13063-021-05261-1.

Clinical effects of breast milk enema on meconium evacuation in premature infants: study protocol for a randomized controlled trial

Liqiang Zheng  1   2   3   4 , Li Gai  1   5 , Jinyue Gao  1   2   3 , Chaonan Kong  1   5 , Yali Wang  1   2   3 , Fangli Sun  1   5 , Sitong Liu  1   2   3 , Xinying Yu  1   5 , Fan Yang  1   5 , Hong Jiang  6   7
Affiliations

Clinical effects of breast milk enema on meconium evacuation in premature infants: study protocol for a randomized controlled trial

Liqiang Zheng et al. Trials. .

Abstract

Background: Delayed meconium evacuation is an important cause of intestinal dysfunction in preterm infants. There are many methods to induce defecation in preterm infants: however, the effects are controversial. Finding a new intervention method to promote meconium evacuation in premature infants is necessary. Therefore, in the proposed study, the effectiveness of breast milk enema on complete meconium evacuation and time to achieve full enteral feeding will be investigated in preterm infants.

Methods/design: The study is a randomized, open-label, parallel-group, and single-center clinical trial. A total of 294 preterm infants will be recruited and stratified based on gestational age. Then, the infants will be assigned in a randomized block design to the intervention and control groups with a 1:1 ratio. Preterm infants in the control and intervention groups will receive saline enema and breast milk enema, respectively. The primary outcomes will be the time to achieve complete meconium evacuation from birth and time to achieve full enteral feeding from birth in preterm infants. The secondary outcomes will include hospitalization days, body weight at discharge, duration of total parenteral nutrition, cholestasis, and adverse events.

Discussion: The results of this trial will determine whether breast milk enema shortens the time to complete meconium evacuation and the time to achieve full enteral feeding in extremely preterm and preterm infants. Furthermore, the study results may provide a new, safe, inexpensive, and easy-to-use intervention to effectively evacuate meconium in preterm infants.

Trial registration: ISRCTN Registry ISRCTN17847514 . Registered on September 14, 2019.

Keywords: Breast milk enema; Complete meconium evacuation; Extremely preterm infants and preterm infants; Full enteral feeding; Randomized controlled trial.

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Conflict of interest statement

The authors declare that they have no competing interests.

Figures

Fig. 1
Fig. 1
Study design of the project
Fig. 2
Fig. 2
The schedule of enrollment, interventions, and assessments
See this image and copyright information in PMC

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