Preterm Neonates and Feeding Clinical Trial
— TOPOfficial title:
Evaluation de la Formation Des infirmières à la Stimulation de l'oralité Des Nouveau-nés Dans Une unité de Réanimation néonatale et Néonatologie : Impact Sur Les Connaissances, Les Pratiques et Sur la qualité Des Soins
| Verified date | March 2017 |
| Source | Hospices Civils de Lyon |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Observational |
Poor oral motor development in preterm neonates is common. Feeding problems lead to longer
hospital stay and higher hospital cost. Different interventions have shown their efficacy to
accelerate transition and move faster to full oral feeding autonomy. Our study aimed to
evaluate the impact of a 2-year education nurse program on feeding pattern and hospital stay
of preterm neonates.
This is an interrupted time series study placed in Intensive Care and Neonatal unit of an
university hospital located in Lyon, France. All preterm neonates are included in the study,
from April 2013 to January 2016.
| Status | Completed |
| Enrollment | 729 |
| Est. completion date | February 2016 |
| Est. primary completion date | February 2016 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 24 Weeks to 34 Weeks |
| Eligibility |
Inclusion Criteria: - Preterm neonates of less than 34 weeks' of gestation - Preterm neonates not requiring surgery with endotracheal intubation - Preterm neonates hospitalized in the Neonatology and Neonatal Intensive Care Unit of an university hospital, Lyon. - Preterm neonates discharged from hospital during the study period from April 2013 to January 2016 --- Exclusion Criteria: - Preterm neonates presenting delivery age above 34 weeks' of gestation - Preterm neonates whose parents have expressed their opposition to participate to the study |
| Country | Name | City | State |
|---|---|---|---|
| France | Hôpital Femme-Mère-Enfant des Hospices Civils de Lyon | Bron | Lyon |
| Lead Sponsor | Collaborator |
|---|---|
| Hospices Civils de Lyon |
France,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Mean age per month of full oral feeding achievement | The age (real and corrected) of weaning of naso-gastric tube of preterm neonates taken out of hospitalization during the month will be computed by subtracting the date of weaning from the date of birth. | Monthly for 34 months | |
| Secondary | Percent of preterm neonates presenting with feeding difficulty symptoms | Preterm neonates will be considered as presenting with feeding difficulty symptoms if they present : no demonstration of hunger cues and/or, Coughing,choking or vomiting during bottle or breast feeding and/or, Feed intake exceeding 30 minutes and/or, Excitement, discomfort or arching of the back during feedings and/or, Gagging or falling asleep during feedings and/or, Refusal to feed. The monthly rate of neonates presenting feeding difficulty symptoms will correspond to the total number of neonates presenting feeding difficulty symptoms divided by the number of neonates hospitalized during the month. |
Monthly for 34 months | |
| Secondary | Mean length of hospital stay per month | Monthly for 34 months | ||
| Secondary | Morbidity and mortality per month | The rate of following neonatal pathologies will be studied : Bronchopulmonary dysplasia, Necrotizing enterocolitis, Periventricular leukomalacia, Intra-ventricular haemorrhage, Premature retinopathy, Hypoxic ischaemic encephalopathy. |
Monthly for 34 months | |
| Secondary | Nurses and childcare assistants' satisfaction concerning the educational session | The opinion of nurses and childcare assistants will be collected about the program contents, the organization and the results waited on their practices of care. The qualities of teaching will be assessed by a 5-point Likert scale. | 34 months |