Evidence map›Paper›PMID 33902678›Full record

ArticleTrials2021

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

Liqiang Zheng, Li Gai, Jinyue Gao, Chaonan Kong, Yali Wang, Fangli Sun, Sitong Liu, Xinying Yu, Fan Yang, Hong Jiang

Open access · goldAbstract readClinical Trial Protocol
In one paragraph

Article in Trials, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 3 papers.

0numbers the graph read from it
0cells of the map it votes in
3citing papers in PubMed
0.7field-weighted citation impact, top 28% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

3 citing papers in PubMed, 4 citations in OpenAlex.

  1. Trial
  2. Trial
  3. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

10 authors at 2 institutions in 1 country.

Liqiang ZhengDepartment of Pediatrics, Shengjing Hospital of China Medical University, Shenyang, 110004, People's Republic of China.
Li GaiDepartment of Pediatrics, Shengjing Hospital of China Medical University, Shenyang, 110004, People's Republic of China.
Jinyue GaoDepartment of Pediatrics, Shengjing Hospital of China Medical University, Shenyang, 110004, People's Republic of China.
Chaonan KongDepartment of Pediatrics, Shengjing Hospital of China Medical University, Shenyang, 110004, People's Republic of China.
Yali WangDepartment of Pediatrics, Shengjing Hospital of China Medical University, Shenyang, 110004, People's Republic of China.
Fangli SunDepartment of Pediatrics, Shengjing Hospital of China Medical University, Shenyang, 110004, People's Republic of China.
Sitong LiuDepartment of Pediatrics, Shengjing Hospital of China Medical University, Shenyang, 110004, People's Republic of China.
Xinying YuDepartment of Pediatrics, Shengjing Hospital of China Medical University, Shenyang, 110004, People's Republic of China.
Fan YangDepartment of Pediatrics, Shengjing Hospital of China Medical University, Shenyang, 110004, People's Republic of China.
Hong JiangDepartment of Pediatrics, Shengjing Hospital of China Medical University, Shenyang, 110004, People's Republic of China. 18940251102@163.com.ORCID http://orcid.org/0000-0003-2857-5538
China Medical University · CNShanghai Jiao Tong University · CN

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundDelayed 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/

designThe 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 registrationISRCTN Registry ISRCTN17847514 . Registered on September 14, 2019.

Indexed as

MeconiumMilk, HumanEnemaFemaleHumansInfantInfant, NewbornInfant, PrematureInfant, Very Low Birth WeightRandomized Controlled Trials as TopicBreast milk enemaComplete meconium evacuationExtremely preterm infants and preterm infantsFull enteral feedingRandomized controlled trial

Identifiers

PMID33902678
PMCPMC8074446
OpenAlexW3157989428

What OpenQuestion holds

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LicenceCC BY
Read underepoch 390

Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.