Effect of topical coconut oil on infection rates in extremely premature infants

Authors
Category Primary study
Registry of TrialsANZCTR
Year 2020
INTERVENTION: Topical coconut oil is the intervention Eligible infants in neonatal units randomised to the study intervention will receive topical coconut oil starting within 24h from birth. Preterm infants’ skin condition deteriorates rapidly in the first days of life therefore commencement of the intervention within 24h of birth is essential. • Infants <25 w GA will receive 5ml of coconut oil 4x/day for the first week of life, then 5ml 2x/day until transferred to an open cot. • Infants >25 w GA will receive 5ml 2x/day until transferred to an open cot. • Once cared for in an open cot, infants will receive topical coconut oil 1x/day until discharge from the tertiary neonatal unit (to minimise undressing and handling of the infant). Application: ‐ Use a new sachet for each application. ‐ The parents should apply the coconut oil to their infant’s skin if they wish, under supervision of the bedside nurse. ‐ Apply topical coconut oil during routine care to the entire skin (front and back). Do not apply coconut oil to the face, scalp, and sites of vascular access or other devices (e.g. chest drain). ‐ Use only a few gentle strokes to apply coconut oil. Do not massage. Application should only take 1‐2 minutes per side. ‐ Discard any unused oil in a sachet after opening. Monitoring Pharmacy stock reports at intervention sites will be compared to the number of eligible infants and expected number of days of treatment will provide an indication of compliance with coconut oil use. Further, monitoring of 20% of eligible infants’ medication charts at the intervention sites, where coconut oil will be prescribed and application signed‐off, will be conducted to ensure compliance with the study intervention. CONDITION: Infection ‐ Studies of infection and infectious agents Late onset sepsis;extremely preterm infants; ; Late onset sepsis ; extremely preterm infants Reproductive Health and Childbirth ‐ Childbirth and postnatal care Reproductive Health and Childbirth ‐ Complications of newborn PRIMARY OUTCOME: Incidence of late onset sepsis; The primary outcome will assessed by the extraction and analysis of of neonatal data reports from the Australia and New Zealand Neonatal Network (ANZNN)[At any time before discharge from neonatal unit.] SECONDARY OUTCOME: Brain injury: Brain injury is defined as Grade of 3 and 4 grade of intraventricular haemorrhage (on either side of the head) seen on ultrasound according to the system of grading defined ANZNN guidelines, or presence by ultrasound any of the following: periventricular leukomalacia, porencephalic cysts or hydrocephalus requiring neurosurgical intervention. ; All secondary outcomes will assessed by the extraction and analysis of of neonatal data reports from the Australia and New Zealand Neonatal Network (ANZNN)[At any time before discharge from neonatal unit] Chronic lung disease: Chronic lung disease (also known as bronchopulmonary dysplasia) is defined as receiving any form of respiratory support for a chronic pulmonary disorder on the day the baby reached 36 weeks’ postmenstrual age. ; All secondary outcomes will assessed by the extraction and analysis of of neonatal data reports from the Australia and New Zealand Neonatal Network (ANZNN)[At any time before discharge from the neonatal unit] Duration of any mechanical ventilation: Mechanical ventilation is defined as respiratory support provided either by endotracheal tube ventilation, continuous positive airway pressure or humidified high‐flow oxygen. ; All secondary outcomes will assessed by the extraction and analysis of of neonatal data reports from the Australia and New Zealand Neonatal Network (ANZNN)[Until discharge from neonatal unit ; ] Time taken to achieve enteral intake of 150 ml/kg/day ; Extract of neonatal data reports from the Australia and New Zealand Neonatal Network (ANZNN)] ; All secondary outcomes will assessed by the extraction and analysis of of neonatal data reports from the Australia and New Zealand Neonatal Network (ANZNN)[At any time before discharge from neonatal unit] Length of hospital stay: Hospital stay is defined as the number of days from admission to final discharge home. ; All secondary outcomes will assessed by the extraction and analysis of of neonatal data reports from the Australia and New Zealand Neonatal Network (ANZNN)[At any time before discharge from the neonatal unit] Necrotizing enterocolitis ; Extract of neonatal data reports from the Australia and New Zealand Neonatal Network (ANZNN)] Retinopathy of prematurity: Stage of retinopathy and necessity for treatment with laser surgery, cryotherapy or monoclonal antibody therapy according to local guidelines. ; All secondary outcomes will assessed by the extraction and analysis of of neonatal data reports from the Australia and New Zealand Neonatal Network (ANZNN)[At any time before discharge from the neonatal unit] Survival ; All secondary outcomes will assessed by the extraction and analysis of of neonatal data reports from the Australia and New Zealand Neonatal Network (ANZNN)[At any time before discharge from neonatal unit. ; All secondary outcomes will assessed by the extraction and analysis of of neonatal data reports from the Australia and New Zealand Neonatal Network (ANZNN)[Time taken to achieve enteral intake of 150 ml/kg/day INCLUSION CRITERIA: Infants born < 28 weeks gestational age
Epistemonikos ID: 4c7f42ad4dded67bc2dfbe734e88016d4dd719d9
First added on: Aug 24, 2024