Techasatid 2017.
Methods | Design: double‐blind RCT Setting: NICU of Thammasat Hospital and Nopparat Rajathanee Hospital, both in Bangkok. Study enrolment: December 2013 and December 2015 I. Allocation concealment: yes II. Blinding of intervention: yes III. Blinding of outcome measurement(s): yes IV. Complete follow‐up: yes |
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Participants | 44 infants enrolled Inclusion criteria: < 30 weeks' gestational age and birth weight < 1250 g who required PN for ≥ 7 days Exclusion criteria: evidence of congenital infection, perinatal asphyxia, congenital anomalies, IVH grade > 2, thrombocytopenia, shock or circulation failure, and renal or hepatic disorders. |
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Interventions | Group 1 (n = 22): MOFS‐LE; 20% SMOFlipid Group 2 (n = 22): S‐LE; 20% Intralipid Lipids were first administered at 1 g/kg/day within 24 hours after birth for both groups; lipid dosage was increased by an increment of 0.5 g/kg/day until the maximal dose of 3.5 g/kg/day was reached. The other macronutrients and micronutrients were provided using the same products and protocol in both groups. Parenteral lipid and amino acid administration were temporarily stopped when either plasma TG concentrations exceeded 250 mg/dL or when urea concentrations exceeded 35 mg/dL respectively. |
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Outcomes | Primary outcomes: incidence of cholestasis, defined as a conjugated bilirubin level > 2 mg/dL on 2 consecutive measurements and biochemical signs of hepatic dysfunction including ALT, AST, ALP and GGT Secondary outcomes: clinical outcomes death; BPD defined as the need for supplementary oxygen or any form of respiratory support at 36 weeks' postmenstrual age; duration of ventilator support (days); NEC stage > 1 on Bell's staging system; ROP as defined by the International Classification of ROP; haemodynamically significant PDA diagnosed by echocardiography as needing treatment by medication or surgery; sepsis defined as a positive blood culture; IVH, all grades, and severe IVH (grade 3 and 4) of Papile classification; duration of hospital stay (days) and growth parameters assessed using in‐hospital growth rates, the gain in head circumference and height from birth until discharge. |
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Notes | ||
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Quote: "Enrolled infants were randomly assigned to a multi component emulsion (study group) or to a pure soybean oil (control group) within 48 hours after birth. Blocks of four stratified randomisations by treatment centres were used." Comment: how random element was generated was not described clearly, but given statements in the study report it was probably done (by author consensus (VK, MM)). |
Allocation concealment (selection bias) | Low risk | Quote: "The allocations were kept in sequentially numbered, opaque, sealed envelopes." Comment: done |
Blinding of participants and personnel (performance bias) All outcomes | Low risk | Quote: "The investigators and the patient care teams were blinded to the treatment allocation and remained throughout the study and the analysis." Comment: possibly done (author consensus (VK, MM)). |
Blinding of outcome assessment (detection bias) All outcomes | Low risk | Quote: "The investigators and the patient care teams were blinded to the treatment allocation and remained throughout the study and the analysis." Comment: possibly done. |
Incomplete outcome data (attrition bias) All outcomes | Low risk | Clinical outcomes reported for most infants. |
Selective reporting (reporting bias) | Unclear risk | Quote: "trial was registered in Clinical Trials.gov (Clinical Trials.gov Identifier: NCT02663453)." Comments: trial registration was done, with first submission on 11 January 2016 which is well past the trial completion. Comments: selective reporting risk could not be assessed. We do not know if the protocol was published elsewhere. |
Other bias | Low risk | Not identified |