Effect of a Parenteral Emulsion With LC-PUFA Omega 3 on Clinical Outcomes, Inflammatory and Oxidative Stress Markers in Neonates With Persistent Pulmonary Hypertension Associated With Congenital Diaphragmatic Hernia

R-2019-785-044

The purpose of this study is to evaluate the effect of a parenteral emulsion containing n-3 long-chain polyunsaturated fatty acids (LC-PUFA) in fish oil on clinical outcomes, markers of inflammation and oxidative stress, and pain in neonates with persistent pulmonary hypertension of the newborn (PPHN) compared with those who receive an emulsion containing soy oil and medium-chain triglycerides (MCT) without n-3 LC-PUFA.

2019-08-12

2024-07-01

2024-12-01

Early phase I

40

Inclusion Criteria: * Plan to administrate TPN for at least 7 days * Clinical, gasometric, and echocardiographic diagnosis of congenital diaphragmatic hernia. * Gestational age \>=34 weeks. * Written informed consent signed by both parents after an explanation of the objectives, procedures and possible risks and benefits of the research, along with the signature of two witnesses Exclusion Criteria: * Diagnosis of complex congenital cardiopathy * Cyanotic congenital cardiology defect * Insufficiency of the tricuspid valve * Immunosuppressive disease. HIV has been associated with PPHN and human herpesvirus with vascular remodeling, perivascular macrophages, and lung fibrosis * Clinical entities that preclude the total parenteral nutrition for one day or longer. * Presence of profuse and persistent haemorrhage at any level Elimination criteria * Parents who withdraw their consent. * Starting a drug at doses for nonclotting treatment such as heparin, enoxaparin. * Development of profuse and persistent haemorrhage at any level after receiving vitamin K treatment.

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE2'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Use of a parenteral emulsion that is used as routine nutrition for newborns but not evaluated for persistent pulmonary hypertension.', 'primaryPurpose': 'PREVENTION', 'maskingInfo': {'masking': 'TRIPLE', 'maskingDescription': 'The attendant gastroenterologist has a randomized allocation and will indicate the type of emulsion during the recruitment. Each emulsion will be designed as a code A or B. The code for each patient is stored into an opaque envelop, which is opened once the parents have given their written informed consent.', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 40, 'type': 'ESTIMATED'}}

2024-02-22