Study of the Effects of CPAP and HHHFNC on Diaphragmatic Dimensions in Preterm Infants
9 mars 2017 uppdaterad av: Hesham Abdel-Hady, Mansoura University Children Hospital
Comparative Study of the Effects of Continuous Positive Airway Pressure and Heated, Humidified High Flow Nasal Cannula on Diaphragmatic Dimensions in Preterm Infants
This is a prospective, randomized crossover study to recognize the effects of nasal continuous positive airway pressure (CPAP) versus heated humidified high flow nasal cannula (HHHFNC) on diaphragmatic dimensions and excursion (evaluated by ultrasonography) in preterm infants.
Studieöversikt
Status
Avslutad
Betingelser
Intervention / Behandling
Detaljerad beskrivning
Preterm infants will be recruited consecutively from NICU of Mansoura University Children's Hospital. They will be randomized in two groups; one group will start on nasal CPAP (Fisher & Paykel Healthcare, Auckland, New Z ealand) (Pressure 5 cmH2O) for 60 minutes and then will be switched to HHHFNC (Fisher & Paykel Healthcare, Auckland, New Z ealand) (flow of 4 l/m) for another 60 minutes. The other group will start on HHHFNC and then switched to nasal CPAP.
After the 2 h study period (2×60 minutes epochs) further respiratory support will be at the discretion of the clinical team.
Ultrasonographic assessment of diaphragmatic dimensions and excursion will be analyzed in different respiratory cycles and the average of 3 cycles will be calculated at the end of the 60 minutes periods on nasal CPAP and HHHFNC.
Studietyp
Interventionell
Inskrivning (Faktisk)
24
Fas
- Inte tillämpbar
Kontakter och platser
Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.
Studieorter
-
-
Dakahlia
-
Mansoura, Dakahlia, Egypten, 35516
- Neonatal Intensive Care Unit, Mansoura University Children Hospital
-
Mansoura, Dakahlia, Egypten, 35516
- NICU, Mansoura University Children's Hospital
-
-
Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
Inte äldre än 1 månad (Barn)
Tar emot friska volontärer
Nej
Kön som är behöriga för studier
Allt
Beskrivning
Inclusion Criteria:
- Preterm infants < 37 weeks.
- Stable on nasal continuous positive airway pressure (CPAP) for at least 24 hours.
- On less than 35% oxygen.
Exclusion Criteria:
- Congenital and acquired problems of the gastrointestinal tract as necrotizing enterocolitis, esophageal perforation and tracheoesophageal fistula.
- Phrenic nerve injury and/or diaphragm paralysis
- Congenital/acquired neurological deficit and/or seizures
- Hemodynamic instability
- Congenital heart disease (including symptomatic patent ductus arteriosus)
- Undergoing treatment for sepsis or pneumonia.
- Use of muscle relaxants, narcotic analgesics, or gastric motility agents.
- Congenital anomalies of respiratory tract.
- Infants requiring more than 35% oxygen.
- Infants with facial anomalies.
- Infants with pneumothorax and/or pneumomediatinum.
- Infants in the immediate postoperative period.
- Infants with significant gastric residues and vomiting.
Studieplan
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Tilldelning: Randomiserad
- Interventionsmodell: Crossover tilldelning
- Maskning: Ingen (Open Label)
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
|
Aktiv komparator: CPAP first
Infant will be given nasal CPAP for 60 minutes and then put on HHHFNC for another 60 minutes.
Ultrasonographic assessment of diaphragmatic dimensions and excursion will be done at the end of the 60 minute periods on nasal CPAP and HHHFNC.
After the 2 h study period (2×60 minutes epochs) further respiratory support will be at the discretion of the clinical team
|
Infants will start on nasal CPAP for 60 minutes and then switched to HHHFNC for anther 60 minutes.
Ultrasonographic assessment of diaphragmatic dimensions and excursion will be done at the end of each 60 minute epochs.
|
|
Aktiv komparator: HHHFNC first
Infant will be given HHHFNC for 60 minutes and then switched to nasal CPAP for another 30 minutes.
Ultrasonographic assessment of diaphragmatic dimensions and excursion will be done at the end of the 60 minute periods on HHHFNC and nasal CPAP.
After the 2 h study period (2×60 minutes epochs) further respiratory support will be at the discretion of the clinical team
|
Infants will start on HHHFNC for 60 minutes and then switched to nasal CPAP for anther 60 minutes.
Ultrasonographic assessment of diaphragmatic dimensions and excursion will be done at the end of each 60 minute epochs.
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Diaphragmatic dimensions (inspiratory diaphragmatic thickness, expiratory diaphragmatic thickness and delta diaphragmatic thickness)
Tidsram: at the end of each 60 minutes epoch on nasal CPAP
|
Ultrasonographic assessment of (inspiratory diaphragmatic thickness, expiratory diaphragmatic thickness and delta diaphragmatic thickness will be assessed at the end of each 60 minutes epoch on nasal CPAP.
Diaphragm thickness will be measured as the perpendicular distance between the pleural and peritoneal reflections.
All measurements will be performed during quiet breathing.
Several respiratory cycles will be recorded, and measurements will be averaged from at least three different cycles.
|
at the end of each 60 minutes epoch on nasal CPAP
|
|
Right and left diaphragmatic excursion
Tidsram: at the end of each 60 minute epoch on CPAP
|
Ultrasonographic assessment of right and left diaphragmatic excursion will be assessed at the end of each 60 minutes epoch on nasal CPAP.
The displacements of the liver and spleen will be monitored in real-time.
Using M-mode ultrasonography, with the probe fixed on the chest wall during respiration, ultrasonographic image of will be frozen and a mark for measurement will be placed on the image at the location of the most caudal margin of the liver or spleen at the end of expiration, and a second mark will be placed on the new location of the most caudal margin of the liver or spleen at the end of inspiration.
The distance between the two marks will be then measured and defined as the displacement of the liver or the spleen (right or left diaphragmatic excursion).
Several respiratory cycles will be recorded, and measurements will be averaged from at least three different cycles.
|
at the end of each 60 minute epoch on CPAP
|
|
Diaphragmatic dimensions (inspiratory diaphragmatic thickness, expiratory diaphragmatic thickness and delta diaphragmatic thickness)
Tidsram: at the end of each 60 minutes epochs on HHHNC
|
Ultrasonographic assessment of (inspiratory diaphragmatic thickness, expiratory diaphragmatic thickness and delta diaphragmatic thickness will be assessed at the end of each 60 minutes epoch on HHHFNC.
Diaphragm thickness will be measured as the perpendicular distance between the pleural and peritoneal reflections.
All measurements will be performed during quiet breathing.
Several respiratory cycles will be recorded, and measurements will be averaged from at least three different cycles.
|
at the end of each 60 minutes epochs on HHHNC
|
|
Right and left diaphragmatic excursion
Tidsram: at the end of each 60 minutes epochs on HHHNC
|
Ultrasonographic assessment of right and left diaphragmatic excursion will be assessed at the end of each 60 minutes epoch on HHHFNC.
The displacements of the liver and spleen will be monitored in real-time.
Using M-mode ultrasonography, with the probe fixed on the chest wall during respiration, ultrasonographic image of will be frozen and a mark for measurement will be placed on the image at the location of the most caudal margin of the liver or spleen at the end of expiration, and a second mark will be placed on the new location of the most caudal margin of the liver or spleen at the end of inspiration.
The distance between the two marks will be then measured and defined as the displacement of the liver or the spleen (right or left diaphragmatic excursion).
Several respiratory cycles will be recorded, and measurements will be averaged from at least three different cycles.
|
at the end of each 60 minutes epochs on HHHNC
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Respiratory rate
Tidsram: At the end of each 60 minutes epochs on CPAP and HHHFNC
|
Respiratory rate will be assessed at the end of each 60 minutes epoch on CPAP or HHHFNC
|
At the end of each 60 minutes epochs on CPAP and HHHFNC
|
|
Heart rate
Tidsram: At the end of each 60 minutes epochs on CPAP and HHHFNC
|
Heart rate will be assessed at the end of each 60 minutes epoch on CPAP or HHHFNC
|
At the end of each 60 minutes epochs on CPAP and HHHFNC
|
|
Spo2
Tidsram: At the end of each 60 minutes epochs on CPAP and HHHFNC
|
Oxygen saturation by pulse oximetry (SpO2) will be assessed at the end of each 60 minutes epoch on CPAP or HHHFNC
|
At the end of each 60 minutes epochs on CPAP and HHHFNC
|
|
Number of apneas
Tidsram: during the 60 minutes epochs on CPAP and HHHFNC
|
Number of apneas will be recorded during the 60 minutes epoch on CPAP or HHHFNC
|
during the 60 minutes epochs on CPAP and HHHFNC
|
Samarbetspartners och utredare
Det är här du hittar personer och organisationer som är involverade i denna studie.
Publikationer och användbara länkar
Den som ansvarar för att lägga in information om studien tillhandahåller frivilligt dessa publikationer. Dessa kan handla om allt som har med studien att göra.
Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart (Faktisk)
1 maj 2015
Primärt slutförande (Faktisk)
1 oktober 2016
Avslutad studie (Faktisk)
1 oktober 2016
Studieregistreringsdatum
Först inskickad
13 april 2015
Först inskickad som uppfyllde QC-kriterierna
17 april 2015
Första postat (Uppskatta)
20 april 2015
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
13 mars 2017
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
9 mars 2017
Senast verifierad
1 mars 2017
Mer information
Termer relaterade till denna studie
Andra studie-ID-nummer
- MS 874
Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .