SURVIVAL RATE OF EXTREMELY LOW BIRTH WEIGHT INFANTS AND ITS RISK

FACTOR : CASE CONTROL STUDY IN JAPAN

Patient/Problem : Survival rate in Infants with extremely low birth weight.

Intervention : Caesarean section

Comparison : Vaginal delivery

Outcome : Caesarean section better than vaginal delivery on the survival of

extremely low birth weight infants

Methods : Case Control Study

Critical Appraisal : Prognostic studies (CEBM, Oxford University)

Are the results of the study valid? (internal validity)

1. Was the defined representative sample of patients assambled at a common (usually early)

point in the course of their disease ?

Answer : Yes

Where :

a. Page 2, 2.1 Study Design and Data Source

Data were collected from 92,630 live births in 2001 and 2002 in the Japan Perinatal

Registry Network database, which was managed by Japan Society of Obstetric and

Gynecology. It includes all live birth and stillbirth at 125 medical center in Japan in

2001 and at 133 medicalcenters in 2002, including almost all level III hospitals. We

restricted our analysis to women who delivered a single live infant at 22 or more

weeks.

2. Was patient follow up sufficiently long and complete?

Answer : Yes
 Where :

a. Page 3, Table 1. Distribution of delivery weeks in this studied population

b. Page 4, Figure 2. Survival rates for cesarean delivery were significantly higher than

those for vaginal delivery from 24 to 31 gestational weeks of delivery in extremely

low birth weight infants. Asteriks indicate statistical significance (P< 0,05)

c. Page 4, Figure 3. Survival rates according to delivery mode in nonvertex presentation

of appropriate-for-date infants.

Page 5, last paragraph. In conclusion, in the present study, in which we did our best to

remove risk factors other than those related to prematurity that affect the viability of

premature infants, ELBW infants with a 50% survival rate were those at week 23 of

gestation or with a birth weight of 500g, and the present result suggested that cesarean

section might improve viability beginning at week 24 of gestation or a birth weight of

>400gr. Since nonvertex presentation, vaginal delivery, and placental abruption are

poor prognostic factors in neonates, when performing vaginal delivery of ELBW

infants at week 24 of gestation or later or with an estimated body weight of >400gr, it

should be contingent on a vertex delivery, and measures may need to be taken to

prevent placental abruption due to intrauterine infection.

3. Were outcome criteria either objective or applied in a “blind” fashion

Answer : No

Where : materials and methods (page 2)

Case identification and putative risk factor selection. ELBW infant was defined as that

born weighing less than 1.000g and very lowbirth weight (VLBW) infant was defined as

less than 1.500g.

 A total of 1,713 ELBW infants born at 22-36 weeks of gestation were registered in 2001

and 2002.

Multiple pregnancy, chromosomal abnormalities and phenotypical anomalies were

excluded.

Case was defined as death at discharge. The other cases , that is survival at discharge,

were used at controls.the relevant variables were compared between the cases (n = 366)

and the controls (n=1.347)

4. If subgroups with different prognoses are identified, did adjustment for important

prognostic factors take place?

Answer : Yes

Where :

a. Page 3, Figure 1: Survival rates for cesarean delivery were significantly higher than

those for vaginal delivery at all birth weight levels in extremely low birth weight

(400-1000g) infants. Asterisks indicate statistical significance (P < 0,05 ).

b. Page 4, Figure 2: Survival rates for cesarean delivery were significantly higher than

those for vaginal delivery from 24 to 31 gestational weeks of delivery in extremely

low birth weight infants. Asteriks indicate statistical significance (P< 0,05).

c. Page 4, Figure 3: Survival rates according to delivery mode in nonvertex presentation

of appropriate-for-date infants.
5. What are the results ?

6. How likely are the outcomes over time ?

7. How precise are the prognostic estimates?

8. Can I apply this valid, important evidence about prognosis to my patients?

The questions that you should ask before you decide to apply the results of the study to

your patients are :

a. Is my patients so different to those in the study that the results cannot apply?

b. Will this evidence make a clinically important impact on my conclusions about what

to offer to tell my patients?