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极低出生体重儿早期口服初乳的短期结局:一项开放标签随机对照试验

Short-Term Outcomes of Early Oral Colostrum Administration in VLBW Neonates: An Open-Label Randomized Controlled Trial.

作者信息

Tehranchi Sedigheh, Palizban Farzaneh, Khoshnood Shariati Maryam, Taslimi Taleghani Naeeme, Fayazi Arefeh, Farjami Mohammad

机构信息

Clinical Research Development Center, Mahdiyeh Educational Hospital, Shahid Beheshti University of Medical Sciences, Tehran, Iran.

Family Health Research Institute, Maternal-Fetal and Neonatal Research Center, Tehran University of Medical Sciences, Tehran, Iran.

出版信息

Med J Islam Repub Iran. 2024 Jan 23;38:7. doi: 10.47176/mjiri.38.7. eCollection 2024.

Abstract

BACKGROUND

Oropharyngeal colostrum priming (OCP) has been proposed as a potential nutritional option for very low birth weight (VLBW) newborns. This study aimed to determine short-term outcomes of early oral colostrum administration in VLBW neonates.

METHODS

This open-label randomized controlled trial was conducted on VLBW neonates admitted to Mahdieh Hospital, Tehran, Iran, between February and December 2022. According to the protocol, all eligible neonates were randomized evenly to the intervention group, which received oral colostrum (OC), and the control group, which received no OC. Finally, short-term outcomes of early OC administration were compared between groups using the independent-samples t test, chi-square, and Fisher exact tests.

RESULTS

Of 80 randomized neonates, 37 and 39 from the intervention and control groups entered the final analysis, respectively. Neonates in the intervention and control groups did not significantly differ in terms of peripherally inserted central catheter (PICC) infection ( = 0.728), sepsis ( = 0.904), necrotizing enterocolitis (NEC) ( > 0.999), intraventricular hemorrhage (IVH) ( = 0.141), retinopathy of prematurity (ROP) ( = 0.923), and bronchopulmonary dysplasia (BPD) ( = 0.633). Furthermore, there was no significant difference between groups considering the time to reach 120 cc/kg feeds ( = 0.557), time to reach birth weight ( = 0.157), length of hospitalization ( = 0.532), and mortality rate ( = 0.628).

CONCLUSION

The results of our study revealed that despite safety, early OC administration did not improve any of the short-term outcomes in VLBW neonates.

摘要

背景

口咽初乳灌注(OCP)已被提议作为极低出生体重(VLBW)新生儿的一种潜在营养选择。本研究旨在确定VLBW新生儿早期口服初乳的短期结局。

方法

本开放标签随机对照试验于2022年2月至12月在伊朗德黑兰马赫迪医院收治的VLBW新生儿中进行。根据方案,所有符合条件的新生儿被均匀随机分为干预组(接受口服初乳(OC))和对照组(不接受OC)。最后,使用独立样本t检验、卡方检验和Fisher精确检验比较两组早期OC给药的短期结局。

结果

80名随机分组的新生儿中,干预组和对照组分别有37名和39名进入最终分析。干预组和对照组新生儿在外周插入中心静脉导管(PICC)感染(P = 0.728)、败血症(P = 0.904)、坏死性小肠结肠炎(NEC)(P > 0.999)、脑室内出血(IVH)(P = 0.141)、早产儿视网膜病变(ROP)(P = 0.923)和支气管肺发育不良(BPD)(P = 0.633)方面无显著差异。此外,在达到120 cc/kg喂养量的时间(P = 0.557)、达到出生体重的时间(P = 0.157)、住院时间(P = 0.532)和死亡率(P = 0.628)方面,两组之间也无显著差异。

结论

我们的研究结果表明,尽管安全,但早期OC给药并未改善VLBW新生儿的任何短期结局。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/ae9c/10907047/7814c5dfa6ad/mjiri-38-7-g001.jpg

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