Enteral Lipid Supplementation and Bronchoplumonary Dysplasia of Premature Infants

Официальное название

Enteral Lipid Supplementation and Bronchoplumonary Dysplasia of Premature Infants: A Randomized Controlled Trial (The PRELUDE Trial)

Обзор

The Impact of Omega-3 (DHA - Docosahexaenoic Acid) and Omega-6 (ARA - Arachidonic Acid) Supplementation on the Development of Bronchopulmonary Dysplasia in Extremely and Very Preterm Infants (24-29 weeks of gestational age).

Подробное описание

The intervention group will receive enteral supplementation with ARA and DHA (in a 2:1 ratio) in addition to standard care and feeding, while the control group will receive standard care and feeding. The intervention will commence within the first three days of life and will continue until 36 weeks postmenstrual age for both groups.

Вмешательства

• Пищевая добавка Enteral supplementation with ARA and DHA (in a 2:1 ratio) in addition to standard care and feeding
  The intervention group will receive enteral supplementation containing arachidonic acid (ARA) and docosahexaenoic acid (DHA) in a 2:1 ratio, in addition to standard care and feeding. Supplementation will begin within the first three days of life and will continue until 36 weeks postmenstrual age.
• Другое Standard care and feeding
  The control group will receive routine clinical care and nutritional support according to current neonatal unit protocols, without additional ARA/DHA supplementation.

Первичные конечные точки

• The presence or absence of bronchopulmonary dysplasia (BPD), as assessed by the need for respiratory support or supplemental oxygen at 36 weeks postmenstrual age. [Срок оценки: Up to 36th week of postmenstrual age]

Вторичные конечные точки (8)

• Classification of BPD [Срок оценки: Up to 36th week of postmenstrual age]
• The presence of comorbidities such as retinopathy of prematurity, necrotizing enterocolitis, intraventricular haemorrhage, periventricular leukomalacia, patent ductus arteriosus, and late-onset sepsis [Срок оценки: Up to 40th week of postmenstrual age]
• Need of respiratory support [Срок оценки: Up to 40th week of postmenstrual age]
• Mean oxygen demand (FiO2) during respiratory support [Срок оценки: Up to 40th week of postmenstrual age]
• Mean tidal volume (ml/kg) during respiratory support [Срок оценки: Up to 36th week of postmenstrual age]
• Mean respiratory rate (RR/min) during respiratory support [Срок оценки: Up to 36th week of postmenstrual age]
• Use of postnatal steroids (yes/no) [Срок оценки: Up to 40th week of postmenstrual age]
• Change in weight z-score from birth to 36 weeks of postmenstrual age [Срок оценки: Up to 36th week of postmenstrual age]

Критерии участия

Критерии включения

Infants born at Papageorgiou Hospital in Neonatology Department and NICU of Aristotle University of Thessaloniki with GA equal to or less than 29 weeks are eligible to participate in the study.

Критерии исключения

Congenital malformations, chromosomal abnormalities or critical illness with short life expectancy.

Study participation requires written informed parental consent within 48h after birth.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Профилактика

Центры проведения

Греция · 1 центр

• Papageorgiou General Hospital — Thessaloniki

Публикации

• Thebaud B, Goss KN, Laughon M, Whitsett JA, Abman SH, Steinhorn RH, Aschner JL, Davis PG, McGrath-Morrow SA, Soll RF, Jobe AH. Bronchopulmonary dysplasia. Nat Rev Dis Primers. 2019 Nov 14;5(1):78. doi: 10.1038/s41572-019-0127-7. PMID 31727986
• Isayama T, Lee SK, Yang J, Lee D, Daspal S, Dunn M, Shah PS; Canadian Neonatal Network and Canadian Neonatal Follow-Up Network Investigators. Revisiting the Definition of Bronchopulmonary Dysplasia: Effect of Changing Panoply of Respiratory Support for Preterm Neonates. JAMA Pediatr. 2017 Mar 1;171(3):271-279. doi: 10.1001/jamapediatrics.2016.4141. PMID 28114678
• Jensen EA, Dysart K, Gantz MG, McDonald S, Bamat NA, Keszler M, Kirpalani H, Laughon MM, Poindexter BB, Duncan AF, Yoder BA, Eichenwald EC, DeMauro SB. The Diagnosis of Bronchopulmonary Dysplasia in Very Preterm Infants. An Evidence-based Approach. Am J Respir Crit Care Med. 2019 Sep 15;200(6):751-759. doi: 10.1164/rccm.201812-2348OC. PMID 30995069
• Svedenkrans J, Stoecklin B, Jones JG, Doherty DA, Pillow JJ. Physiology and Predictors of Impaired Gas Exchange in Infants with Bronchopulmonary Dysplasia. Am J Respir Crit Care Med. 2019 Aug 15;200(4):471-480. doi: 10.1164/rccm.201810-2037OC. PMID 30789787
• Abman SH, Collaco JM, Shepherd EG, Keszler M, Cuevas-Guaman M, Welty SE, Truog WE, McGrath-Morrow SA, Moore PE, Rhein LM, Kirpalani H, Zhang H, Gratny LL, Lynch SK, Curtiss J, Stonestreet BS, McKinney RL, Dysart KC, Gien J, Baker CD, Donohue PK, Austin E, Fike C, Nelin LD; Bronchopulmonary Dysplasia Collaborative. Interdisciplinary Care of Children with Severe Bronchopulmonary Dysplasia. J Pediatr PMID 27908648
• Walsh MC, Wilson-Costello D, Zadell A, Newman N, Fanaroff A. Safety, reliability, and validity of a physiologic definition of bronchopulmonary dysplasia. J Perinatol. 2003 Sep;23(6):451-6. doi: 10.1038/sj.jp.7210963. PMID 13679930
• Jobe AH, Bancalari E. Bronchopulmonary dysplasia. Am J Respir Crit Care Med. 2001 Jun;163(7):1723-9. doi: 10.1164/ajrccm.163.7.2011060. No abstract available. PMID 11401896
• Davidson LM, Berkelhamer SK. Bronchopulmonary Dysplasia: Chronic Lung Disease of Infancy and Long-Term Pulmonary Outcomes. J Clin Med. 2017 Jan 6;6(1):4. doi: 10.3390/jcm6010004. PMID 28067830

Идентификаторы

NCT: NCT07652684 · 393/16-01-2025

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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