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Effect of inhaled hypertonic saline solution to treat infants hospitalizid with viral bronchiolitis.

Effect of inhaled hypertonic saline solution to treat infants hospitalizid with viral bronchiolitis.

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON27764
Enrollment
161
Registered
2008-10-15
Start date
2009-08-01
Completion date
Unknown
Last updated
2024-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

viral bronchiolitis hypertonic saline solution infants hypertoon zout zuigelingen RSV

Interventions

All children included in the study will have a nasopharyngeal lavage. Therefor 1 cc of NaCl 0,9% is injected by a 2cc-syringe in each side of the nose. Then the nasopharyngeal secretion is sucked out
Romedic BV
Meersen, the Netherlands) will be used in all patients. Before and after nebulisation the heart rate, transcutaneous oxygen saturation, respiratory rate, temperature and Wang score will be recorded.2

Sponsors

none
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. Infants younger than 24 months admitted with a viral bronchiolitis (prolonged and/or wheezing exspiration, tachypnoe and dyspnoe), a Wang-score of two or more and without a positive reaction on Salbutamol inhalation are included, after informed parental consent.

Exclusion criteria

Exclusion criteria: 1. Haemodynamically important congenital cardiac disease. 2. Chronic pre-existent respiratory disease, T-cell immunodeficienty and admission of the patient with a viral bronchiolitis not due to clinical reasons, for instance social problems. 3. Infants who are treated with systemic corticosteroids will also be excluded from the study. 4. Infants suspected to have underlying asthma and/or allergy. This includes infants with eczema or food-allergy.

Design outcomes

Primary

MeasureTime frame
- The primary end point is the time to discharge, including duration of the treatment following a possible transfer to a paediatric intensive care unit. Discharge is defined as the time from which no additional oxygen therapy is required (oxygen saturation in rest in room air > 95%) and / or no need for intravenous fluids or gastric tube feeding for at least 12 hours. These criteria apply even in cases where actual discharge from hospital is delayed for logistical or social reasons.

Secondary

MeasureTime frame
- The secondary study parameters include the need for transfer to a pediatric intensive care unit (PICU) if there is the need of mechanical ventilation, the length of supplemental oxygen requirement, and the need for additional support measure such as enteral feeding, antibiotics or bronchus dilator therapy. The following parameters will be registered: - positive immunoflourescent test for RSV, - influenza, - para-influenza or rhino- virus, - wang score before and after therapy.

Contacts

Public ContactB. Loza

VieCuri Medisch Centrum voor Noord-Limburg.

bettinaloza@viecuri.nl+31 (0)77 3205183

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)