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NEONATAL HEMATOCRIT
I BACKGROUND
Cord clamping in relation to delivery of the newborn is still flocked with many
controversial issues. The usual practice is to clamp the cord after 10-15 seconds from
birth. However, there has been no sound evidence in favor of this approach
in comparison to the millennial practice of clamping the cord between 1 and 3 minutes
after birth.1-2 Three studies observed that delayed cord clamping could contribute to
review confirms the benefit of delayed cord clamping. 6 The reason for this effect is
based on the fact that after birth the newborn is delivered with a placental transfusion
Compared with early clamping, a delay of around 2–3 min provides an additional
of iron added to iron stores, sufficient to meet the needs of a 6–11 month-old infant for
II RESEARCH QUESTION:
What is the effect of delayed cord clamping on the venous hematocrit of term,
To compare the effect of delayed versus early cord clamping on the venous
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SPECIFIC OBJECTIVES:
1. To determine the clinical profile of term neonates among those with early versus
neonates among those with cord clamping done within 10 seconds and those
after 3 minutes.
neonates with early versus delayed cord clamping done at 6 weeks and at 3
months post-natal.
with a standard deviation of ±8% between early versus delayed (two-tailed test)
yielding a type 1 error of 10% and generating a power of 90%, with a variance of 2%,
2
n= 44 per arm
4.2 Study Design: Randomized controlled trial comparing cord clamping done
4.3 Setting: San Juan De Dios General Hospital . In this institution, the cord
The primary endpoints of this study include the hematological and iron status of
Women eligible to participate are there not in advanced labour (The Mother had
instrumental delivery, serious haemorrhage during pregnancy or delivery, the need for
did not have any of the following basic characteristics: planned delivery by caesarean
established by the date of last menstrual period or estimated delivery date; or multiple
gestation.
Exclusion Criteria : Women will be excluded if they had a diagnosis of any of the
at any time of diabetes (all types), hypertension, cardiopathies, or chronic renal disease
and hematological dyscrasias. Behavioural criteria for exclusion include those women
not planning to breastfeed for at least 6 months, if they smoked at all during
pregnancy, if unwilling to return for follow-up visits at the same hospital, or were
participating in another research study at the hospital. Written informed consent will be
obtained from
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4.6 Inclusion Criteria of Neonates
All live births with the following criteria: 1.) Term by sonographic as well as clinical
maturity rating 2.) Good APGAR scores 3.) informed parental consent
Exclusion Criteria : 1.) Those with jaundice at birth 2.) respiratory depression 3.)
infants born to mothers incurring severe maternal blood loss 3.) No parental consent
four using the random digit generator in Microsoft Excel. Numbered index cards
randomi with the assigned treatment will be sealed in corresponding numbered opaque
envelopes and ordered sequentially. Before delivery, the next envelope will be opened
by recruitment staff , who will inform the obstetrician and the pediatrician attending the
delivery of the assigned treatment. Study staff will not inform the mother of her
assignment; however, because of the nature of the intervention, the mothers may be
assigned to a treatment group later became ineligible (eg, method of delivery changed
to caesarean), her assigned treatment card will not be re-used. At all births, a staff
member is present to measure the time from the delivery of the infant’s shoulders to
the cord clamping. Obstetricians will be asked to maintain the infant at the level of the
mother’s uterus until the cord is clamped. In the early-clamping group, the staff
member informed the obstetrician when 10 second have passed and that the cord
should be clamped. In the delayed delayed clamping group, the staff member will
inform the
obstetrician of the passing time until 3 min (the intended clamping time). If the
physician feel that the infant or the mother needs attention that could not be given
while the infant remained attached to the umbilical cord, the cord will be clamped
before this time; however, original group assignment will not be changed. Exclusion
criteria applied after birth are low birth weight (<2500 g) and major congenital
malformations. Venous blood samples will be taken from the mother before delivery
4
and from the umbilical vein in the placenta immediately after its delivery. Obstetricians
will estimate the amount of maternal blood loss during the delivery and immediately
afterwards as normal, high, or severe. Infant weight and length will be measured
shortly after birth. Recruitment and follow-up staff were trained and standardized (a
in standard anthropometric techniques. Capillary blood sample will be taken from the
infant’s heel. Before discharge from the hospital, study staff will record medical chart
information on complications or medical procedures for the infant and mother, and
At 6 weeks and 3 months, the mother and her child will be scheduled for a
follow-up check-up. Hematocrit values will be obtained during these visits and data
collated. The routine well-baby check-up will follow. Subgroup analysis will be done to
adjust for effect of formula milk feeding and multivitamin and mineral used.
Since maternal nutrition, duration of breast feeding and use of formula feeding
are extraneous variables that can effect our study, a special subgroup analysis for
V STATISTICAL ANALYSIS
conducted using the SPSS version 14. Descriptive statistics include means and SD.
Testing for baseline homogeneity will be performed using Chi-square and independent
T-testing. Repeated ANOVA with post-hoc analysis will be done to determine significant
interaction between groups (early and late clamping) and venous hematocrit. A
neonates.
All p-values of less than .05 will be considered statistically significant. Precision
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VI Ethical Considerations
The protocol will be submitted for Ethics Committee Review. The provisions of
the protocol conform to the Declaration of Helsinki and Ethics of Good Medical Research
Issues on confidentiality, autonomy and voluntary withdrawal from the study are
REFERENCES:
1 World Health Organization. Care of the Umbilical Cord: A Review of the Evidence.
Geneva, Switzerland: World Health Organization; 1998:11–12.
WHO/RHTMSM/98.4
2 Mercer JS. Current best evidence: a review of the literature on umbilical cord
clamping. J Midwifery Womens Health. 2001;46: 402–414
6
5 Ceriani Cernadas, J. M., Carroli, G., Pellegrini,L., Otan˜o, L., Ferreira, M., Ricci,
C., et al.(2006). The effect of timing of cord clamping on neonatal venous
hematocrit values and clinical outcome at term: A randomized, controlled
trial. Pediatrics, 117(4), e779–787.
7 Linderkamp O, Nelle M, Kraus M, Zilow EP. The effect of early and late cord-
clamping on blood viscosity and other hemorheological parameters in full-term
neonates. Acta Paediatr. 1992;81:745–750
9 Usher R, Shephard M, Lind J. The blood volume of the newborn infant and
placental transfusion. Acta Paediatr 1963; 52: 497–512.
7
1 min=___________
Birth Length=__________cm
5 mins=__________
8
We, Jean Peter Siregar and Andre Inigo, third year pediatric residents of this
institution would like to ask for your kind permission and cooperation regarding our
studies :
1. EFFECT OF EARLY SKIN-TO-SKIN CONTACT (WITHIN 120 MINUTES) AFTER
DELIVERY ON DURATION OF BREASTFEEDING. A Randomized Controlled Trial.
The protocol has passed the Research Ethics Committee of The Department and
this m will be submitted to the Hospital Research Committee. For details, a copy of the
protocol is attached per your disposal.
Sincerely,
Endorsed by:
Milagros Bacsain-Andres MD
Research Committee, Department of Pediatrics