None listed
Conditions
Brief summary
Breathing events are common in premature babies cared for in the neonatal unit. This study aims to evaluate the impact of position changes and feeding changes on breathing events in preterm babies managed in a neonatal unit. Babies recruited through this study underwent three care conditions: 1. Care as usual (baby nursed flat on back, with normal tube feeds) 2. Positional intervention (baby nursed on stomach with the cot propped, with normal tube feeds) 3. Feed rate intervention (baby nursed flat on back, with tube feed given over 45min). We predict that position or feed rate changes may reduce breathing events in preterm infants.
Interventions
Position Intervention
Infants undertaking Condition A (‘supine and flat’) were placed supine with the cot in neutral (horizontal) position. The positional intervention, Condition B (‘propped and prone’), combined infant position and cot position, with infants placed prone with head turned to one side and cot inclined at 15 degrees (default cot elevation achievable within the unit). Positioning during Conditions A and B was maintained as default position throughout each 24-hour test period, but a
Position Intervention Infants undertaking Condition A (‘supine and flat’) were placed supine with the cot in neutral (horizontal) position. The positional intervention, Condition B (‘propped and prone’), combined infant position and cot position, with infants placed prone with head turned to one side and cot inclined at 15 degrees (default cot elevation achievable within the unit). Positioning during Conditions A and B was maintained as default position throughout each 24-hour test period, but allowed for position change for routine nursing and medical care. Positions were administered by the caring registered nurse. Parent handling (holding and skin-to-skin) was encouraged, however avoided during and within one hour of feeding. Feed-Rate Intervention Infants in Conditions A and B received usual third-hourly gravity bolus feeds via nasogastric tube, typically over 5 to 15 minutes. The feed-rate intervention (Condition C) was defined by third-hourly feed volume given over 45 minutes by pump, with usual supine/flat infant position. Pump feeds were administered via Vygon (Écouen, France) Nutrisafe-2 pump and giving set. Feeds were standard (expressed breast milk or standard hospital formula [67-81kcal/100mL as standard practice within unit]) Each condition occurred for a 24 hour period, in randomised sequence, consecutively over three days without washout period. Adherence to conditions was supported by nursing team leader and supported nursing handover.
Sponsors
Pita Birch
Study design
Allocation
Randomised controlled trial
Intervention model
Crossover
Primary purpose
Treatment
Masking
Blinded (masking used) (Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
No minimum to 32 Weeks
Healthy volunteers
No
Inclusion criteria
Inclusion Criteria Preterm Infants less than 32 weeks gestation at birth can be enrolled in the study at any gestation and become eligible to enter the study period once they have met the additional criteria below: • Off respiratory support for at least 5 days o Infants who are on low flow sub-nasal oxygen less than 0.5 L/min are eligible (oxygen flow rate will not be weaned during the trial) o Infants who are receiving Caffeine Citrate will not be excluded, but the caffeine dose will only be adjusted for body weight during the trial and will not be discontinued during the trial regardless of gestational age • Receiving full enteral feeds (greater than or equal to 150 mL/kg/day) for at least 5 days • Receiving 3 hourly feeding for at least 48 hours [note maximum age listed below refers to gestational age - there was no exclusion based on chronological age]
Exclusion criteria
Exclusion Criteria • Currently receiving respiratory support: o High-flow nasal cannula therapy (HFNC) o Continuous Positive Airway Pressure (CPAP) o Nasal Intermittent Positive Pressure Ventilation (NIPPV) o Conventional or Oscillatory Ventilation • Significant comorbidity: o History of confirmed necrotising enterocolitis (NEC) o Past surgery or condition likely to require surgery (other than inguinal hernia) o Significant or symptomatic congenital heart disease o Congenital airway obstruction (Pierre-Robin Sequence etc.) • Discharge likely to occur during the trial • Receiving nutritive suck feeds (breast or bottle feeds if counted in total fluid intake) • Receiving pharmacological treatment for Gastro-oesophageal Reflux Disease (GORD) • Infants for whom a decision to provide palliative care has been made
Outcome results
None listed