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Identification of practices and morbidities affecting the mortality of very low birth weight infants using a multilevel logistic analysis: clinical trial or standardisation?

Kusuda S, Fujimura M, Uchiyama A, Nakanishi H, Totsu S, for Neonatal Research Network, Jap - BMJ Open (2013)

Bottom Line: A multivariate logistic model identified practices and morbidities associated with mortality.Then, those which were significantly associated with mortality were analysed using a multilevel logistic model.In contrast, necrotising enterocolitis showed the lowest variation (0.1) and a high OR (4.9).

View Article: PubMed Central - PubMed

Affiliation: Department of Neonatal Medicine, Maternal and Perinatal Center, Tokyo Women's Medical University, Tokyo, Japan.

ABSTRACT

Objectives: To determine the feasibility of clinical trials of newly developed treatments or standardisation of existing practices to further improve outcomes among very low birth weight (VLBW) infants, a nationwide database was analysed with a two-dimensional approach using two multivariate logistic models.

Design: Retrospective observational analysis.

Setting: Level III perinatal centres in Japan.

Participants: 15 920 VLBW infants admitted at 38 participating centres from 2003 through 2010.

Outcome measures: Clinical information for the infants was collected until discharge from the centres. A multivariate logistic model identified practices and morbidities associated with mortality. Then, those which were significantly associated with mortality were analysed using a multilevel logistic model. The residues calculated by the multilevel analysis were used as an indicator of centre variation.

Results: Among practices, antenatal steroids and intubation at birth showed relatively high centre variations (0.9 and 0.8) and favourable ORs (0.7 and 0.5) for mortality, while caesarean section showed a low centre variation (0.4) and a favourable OR (0.8). Sepsis and air leak showed high centre variations (0.4 and 0.4) and high ORs (3.8 and 3.4) among morbidities. Pulmonary haemorrhage, persistent pulmonary hypertension of the newborn, and intraventricular haemorrhage showed moderate variations (0.2, 0.3 and 0.2, respectively) and high ORs (5.6, 4.1 and 2.9, respectively). In contrast, necrotising enterocolitis showed the lowest variation (0.1) and a high OR (4.9).

Conclusions: The two-dimensional approach has clearly demonstrated the importance of clinical trial or standardisation. The practices and morbidities with low centre variations and high ORs for mortality must be improved through clinical trials of newly introduced techniques, while standardisation must be considered for practices and morbidities with a high centre variation.

Trial registration: The database was registered as UMIN000006961.

No MeSH data available.


Related in: MedlinePlus

Flow chart of registration and evaluation. Total 17 156 infants whose birth weight at or less than 1500 g were registered on the database. Among them, 33 infants with delivery room death regardless of vigorous resuscitation, 1168 infants with major congenital anomalies and 35 infants with incomplete registration were excluded from the study. Thus, the number of infants evaluated was 15 920, which were reported from 38 hospitals during the study year 2003 through 2010.
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BMJOPEN2013003317F1: Flow chart of registration and evaluation. Total 17 156 infants whose birth weight at or less than 1500 g were registered on the database. Among them, 33 infants with delivery room death regardless of vigorous resuscitation, 1168 infants with major congenital anomalies and 35 infants with incomplete registration were excluded from the study. Thus, the number of infants evaluated was 15 920, which were reported from 38 hospitals during the study year 2003 through 2010.

Mentions: A neonatal research network database in Japan was used in the current study. The database included infants with birth weights at or less than 1500 g who were treated in participating neonatal centres. To characterise the risk of each practice or morbidity with mortality and their centre variation among hospitals, 17 156 infants born from 2003 through 2010 at 38 hospitals that participated in the network throughout the 8 years were analysed. Among all the infants, 33 infants died in the delivery room, and 1168 infants with major congenital anomalies were excluded from the study because mortality in those infants was beyond the quality of NICU care. Furthermore, 35 infants were also excluded due to incomplete data registration. Thus, 15 920 infants were included in the study (figure 1). All 38 hospitals were designated as level III perinatal centres. The definitions of the collected variables were as previously reported, and are available on the web (http://plaza.umin.ac.jp/nrndata/).7


Identification of practices and morbidities affecting the mortality of very low birth weight infants using a multilevel logistic analysis: clinical trial or standardisation?

Kusuda S, Fujimura M, Uchiyama A, Nakanishi H, Totsu S, for Neonatal Research Network, Jap - BMJ Open (2013)

Flow chart of registration and evaluation. Total 17 156 infants whose birth weight at or less than 1500 g were registered on the database. Among them, 33 infants with delivery room death regardless of vigorous resuscitation, 1168 infants with major congenital anomalies and 35 infants with incomplete registration were excluded from the study. Thus, the number of infants evaluated was 15 920, which were reported from 38 hospitals during the study year 2003 through 2010.
© Copyright Policy - open-access
Related In: Results  -  Collection

License
Show All Figures
getmorefigures.php?uid=PMC3753512&req=5

BMJOPEN2013003317F1: Flow chart of registration and evaluation. Total 17 156 infants whose birth weight at or less than 1500 g were registered on the database. Among them, 33 infants with delivery room death regardless of vigorous resuscitation, 1168 infants with major congenital anomalies and 35 infants with incomplete registration were excluded from the study. Thus, the number of infants evaluated was 15 920, which were reported from 38 hospitals during the study year 2003 through 2010.
Mentions: A neonatal research network database in Japan was used in the current study. The database included infants with birth weights at or less than 1500 g who were treated in participating neonatal centres. To characterise the risk of each practice or morbidity with mortality and their centre variation among hospitals, 17 156 infants born from 2003 through 2010 at 38 hospitals that participated in the network throughout the 8 years were analysed. Among all the infants, 33 infants died in the delivery room, and 1168 infants with major congenital anomalies were excluded from the study because mortality in those infants was beyond the quality of NICU care. Furthermore, 35 infants were also excluded due to incomplete data registration. Thus, 15 920 infants were included in the study (figure 1). All 38 hospitals were designated as level III perinatal centres. The definitions of the collected variables were as previously reported, and are available on the web (http://plaza.umin.ac.jp/nrndata/).7

Bottom Line: A multivariate logistic model identified practices and morbidities associated with mortality.Then, those which were significantly associated with mortality were analysed using a multilevel logistic model.In contrast, necrotising enterocolitis showed the lowest variation (0.1) and a high OR (4.9).

View Article: PubMed Central - PubMed

Affiliation: Department of Neonatal Medicine, Maternal and Perinatal Center, Tokyo Women's Medical University, Tokyo, Japan.

ABSTRACT

Objectives: To determine the feasibility of clinical trials of newly developed treatments or standardisation of existing practices to further improve outcomes among very low birth weight (VLBW) infants, a nationwide database was analysed with a two-dimensional approach using two multivariate logistic models.

Design: Retrospective observational analysis.

Setting: Level III perinatal centres in Japan.

Participants: 15 920 VLBW infants admitted at 38 participating centres from 2003 through 2010.

Outcome measures: Clinical information for the infants was collected until discharge from the centres. A multivariate logistic model identified practices and morbidities associated with mortality. Then, those which were significantly associated with mortality were analysed using a multilevel logistic model. The residues calculated by the multilevel analysis were used as an indicator of centre variation.

Results: Among practices, antenatal steroids and intubation at birth showed relatively high centre variations (0.9 and 0.8) and favourable ORs (0.7 and 0.5) for mortality, while caesarean section showed a low centre variation (0.4) and a favourable OR (0.8). Sepsis and air leak showed high centre variations (0.4 and 0.4) and high ORs (3.8 and 3.4) among morbidities. Pulmonary haemorrhage, persistent pulmonary hypertension of the newborn, and intraventricular haemorrhage showed moderate variations (0.2, 0.3 and 0.2, respectively) and high ORs (5.6, 4.1 and 2.9, respectively). In contrast, necrotising enterocolitis showed the lowest variation (0.1) and a high OR (4.9).

Conclusions: The two-dimensional approach has clearly demonstrated the importance of clinical trial or standardisation. The practices and morbidities with low centre variations and high ORs for mortality must be improved through clinical trials of newly introduced techniques, while standardisation must be considered for practices and morbidities with a high centre variation.

Trial registration: The database was registered as UMIN000006961.

No MeSH data available.


Related in: MedlinePlus