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足月和晚期早产儿早期与晚期肠外营养的随机对照试验。

Early versus late parenteral nutrition in term and late preterm infants: a randomised controlled trial.

机构信息

Pharmacy Department, Perth Children's Hospital, Nedlands, Western Australia, Australia

Medical School, The University of Western Australia, Perth, Western Australia, Australia.

出版信息

BMJ Paediatr Open. 2024 May 12;8(1):e002579. doi: 10.1136/bmjpo-2024-002579.

DOI:10.1136/bmjpo-2024-002579
PMID:38735834
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC11097870/
Abstract

BACKGROUND

There is limited evidence regarding the optimal time to commence parenteral nutrition (PN) in term and late preterm infants.

DESIGN

Single-centre, non-blinded, exploratory randomised controlled trial.

SETTING

A level-3 neonatal unit in a stand-alone paediatric hospital.

PATIENTS

Infants born ≥34 weeks of gestation and ≤28 days, who needed PN. Eligible infants were randomised on day 1 or day 2 of admission.

INTERVENTIONS

Early (day 1 or day 2 of admission, N=30) or late (day 6 of admission, N=30) PN.

MAIN OUTCOME MEASURES

Plasma phenylalanine and F-isoprostane levels on day 4 and day 8 of admission. Secondary outcomes were amino-acid and fatty-acid profiles on day 4 and day 8, and clinical outcomes.

RESULTS

The postnatal age at randomisation was similar between the groups (2.3 (SD 0.8) vs 2.3 (0.7) days, p=0.90). On day 4, phenylalanine levels in early-PN infants were higher than in late-PN (mean (SD) 62.9 (26.7) vs 45.5 (15.3) µmol/L; baseline-adjusted percentage difference 25.8% (95% CI 11.6% to 39.9%), p<0.001). There was no significant difference in phenylalanine levels between the two groups on day 8. There was no significant difference between the groups for F-isoprostane levels on day 4 (early-PN mean (SD) 389 (176) vs late-PN 419 (291) pg/mL; baseline-adjusted percentage difference: -4.4% (95% CI -21.5% to 12.8%) p=0.62) and day 8 (mean (SD) 305 (125) vs 354 (113) pg/mL; adjusted mean percentage difference -16.1 (95% CI -34.1 to 1.9) p=0.09).Postnatal growth restriction for weight was less severe in the early-PN group (change in weight z-score from baseline to discharge: -0.6 (0.6) vs -1.0 (0.6); p=0.02). The incidence of hyperglycaemia was greater in the early-PN group (20/30 (66.7%) vs 11/30 (36.7%), p=0.02).

CONCLUSIONS

The timing of the commencement of PN did not seem to affect the degree of oxidative stress in critically ill term and late preterm infants. The effect of transiently high plasma phenylalanine with early PN on clinical outcomes requires further investigation.

TRIAL REGISTRATION NUMBER

ACTRN12620000324910.

摘要

背景

关于足月和晚期早产儿何时开始肠外营养(PN),证据有限。

设计

单中心、非盲、探索性随机对照试验。

地点

一家独立儿科医院的 3 级新生儿病房。

患者

胎龄≥34 周且≤28 天,需要 PN 的婴儿。符合条件的婴儿在入院第 1 天或第 2 天随机分组。

干预

早期(入院第 1 天或第 2 天,n=30)或晚期(入院第 6 天,n=30)PN。

主要观察指标

入院第 4 天和第 8 天的血浆苯丙氨酸和 F-异前列烷水平。次要结局指标为入院第 4 天和第 8 天的氨基酸和脂肪酸谱以及临床结局。

结果

随机分组时的新生儿胎龄在两组间相似(2.3(SD 0.8)vs 2.3(0.7)天,p=0.90)。入院第 4 天,早期 PN 婴儿的苯丙氨酸水平高于晚期 PN(平均(SD)62.9(26.7)vs 45.5(15.3)µmol/L;基线调整后的百分比差异 25.8%(95%CI 11.6%至 39.9%),p<0.001)。第 8 天两组间苯丙氨酸水平无显著差异。第 4 天两组间 F-异前列烷水平无显著差异(早期 PN 平均(SD)389(176)vs 晚期 PN 419(291)pg/mL;基线调整后的百分比差异:-4.4%(95%CI-21.5%至 12.8%),p=0.62)和第 8 天(平均(SD)305(125)vs 354(113)pg/mL;调整后的平均百分比差异-16.1%(95%CI-34.1%至 1.9%),p=0.09)。早期 PN 组的新生儿体重生长受限程度较轻(从基线到出院时体重 z 评分的变化:-0.6(0.6)vs-1.0(0.6);p=0.02)。早期 PN 组高血糖的发生率更高(20/30(66.7%)vs 11/30(36.7%),p=0.02)。

结论

PN 开始时间似乎不会影响危重症足月和晚期早产儿的氧化应激程度。早期 PN 时短暂的高血浆苯丙氨酸对临床结局的影响需要进一步研究。

临床试验注册号

ACTRN12620000324910。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/89f4/11097870/3a4e7ecdc164/bmjpo-2024-002579f01.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/89f4/11097870/3a4e7ecdc164/bmjpo-2024-002579f01.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/89f4/11097870/3a4e7ecdc164/bmjpo-2024-002579f01.jpg

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