Delayed cord clamping

1. Dr. Zaheen Zehra N
1st Year MD PAEDIATRICS
JOURNAL CLUB

2. Effect of Delayed Cord Clamping on
Hematocrit, Thermal and
Hemodynamic Stability in Preterm
Neonates: Randomized Controlled
Trial.
 Indian Pediatrics.
Received: January 23, 2016;
Initial review: March 26, 2016;
Accepted: December 22, 2016.

3. Indian Pediatrics
 The official publication of the Indian Academy of Paediatrics
(IAP),
 Indexed by leading international services including Index
Medicus.
 The journal began publication in 1963.
 Indian Paediatrics has a permanent Editorial Office situated at
New Delhi, India.
 It is published monthly and has a current circulation of about
23,000.
 The journal gives priority to reports of outstanding clinical and
experimental work as well as important contributions related to
common and topical problems in India and the developing
countries

4. AUTHORS
 Niraj Kumar Dipak, Ruchi Nimish Nanavati, Nand
Kishore Kabra, Anita Srinivasan and Anitha
Ananthan.
 From Department of Neonatology,
Seth GS Medical College and KEM Hospital,
Parel, Mumbai
Correspondence to: Dr Niraj Kumar Dipak,
Department of Neonatology,
Seth GS Medical College.

5. OBJECTIVE
 To Evaluate the short term clinical
effects of Delayed cord clamping in
Preterm Neonates.

6. OUTCOMES
 Primary Outcome:
1. Hematocrit at 4 Hours of age.
 Secondary Outcome:
1. Temperature on Admission.
2. Heart rate and NIBP at 12 Hours.
3. Urinary Output for initial 72 Hours.
4. Number of Red cell transfusions, TSB at 72
Hours.
5. Peak Serum Bilirubin(PSB).
6. Evidence of IVH, ROP, LONS and NEC stage
2.

7. METHODOLOGY
 Study Design: Randomized controlled trial.
 Setting: A Tertiary Care Neonatal Unit From Oct
2013 to Sep 2014.
 Participants: 78 mothers with Preterm Labour
between 27 to 31+6 weeks of Gestation.

8. SELECTION CRITERIA
 Inclusion Criteria:
Mothers with 27 to 31+6 weeks of gestation with
Preterm onset of Labour were included to
Participate in the Study.

9.  Exclusion Criteria:
1. Multiple Gestation.
2. Rh –ve status.
3. Placenta Previa or Abruptio Placenta.
4. Fetus with Major Congenital Anomalies.
5. Hydrops.
6. Fetal growth restriction with abnormal Doppler
waveforms.
7. Evidence of Fetal Distress

10. INTERVENTION DONE
 Early Cord Claming(10s).
 Delayed Cord Clamping(60s).
 Delayed Cord Clamping(60s) along with
Intramuscular Ergometrine(500mcg) Administered
to the Mother.

11. Grouping of Subjects
 Random Number Sequence with Variable block
size of 3 or 6 using a ‘Random Allocation
Software’ Program.
 Allocation concealment was done by sequentially
numbered sealed opaque envelopes.
 Sequence was generated by a Statistician who
was not a part of the Study.

12. Post Intervention in Labour
Room
 Antenatal and Delivery Details were entered in
Mother’s Chart.
 Umblical cord blood was collected for Blood gas
analysis.
 Timing of Cord clamping Recorded.
 Apgar score at 1 min and 5 mins were recorded.
 Time of Birth Recorded.
 Axillary Temperature was recorded with mercury
thermometer in labour room at 5 mins.
 Shifted to NICU post Stabilization.

13. In NICU
 At 4 hours of age: Venous Sample for
Hematocrit.
 At 12 hours of age: Heart Rate, Mean NIBP, CRIB
score, Max FiO2 requirement.
 During initial 24 hours: Respiratory Support
requirement, Surfactant Requirement.
 Arterial/Alveolar ratio at 24 hour.
 For initial 72 hours: Urine Output.
 7, 14 days and 40 weeks PMA: USG cranium.
 Followed up ROP screening and Subsequent
retinal examinations.

14. Crib Score

15. Participant Flow in the study

16. Statistics

17. Statistical Methods
 Sample size calculation was based on Venous
hematocrit at 4 hours of age in immediately
clamped infants.
 Estimated sample size of 90 (30 in each
group)
 Statistical analysis was performed using
SPSS version 16.
 A two sided p value <0.05 was considered
significant

18. Comparison of Baseline Characteristics in The three
study groups.

19. Comparison of Outcomes in 3 study
groups

20. Results
ECC- Mean(SD) DCC1 DCC2E
Venous
Hematocrit at 4
hours
47.6(1.3%) 58.9(2.5%) 58.7(2.1%)
Vasopressor
Support
6 infants 1 infant 2 infants
Blood
transfusion
11(40.7%) 2(7.7%) 1(4%)
TSB 5.6(1.5)mg/dl 9.4(3.4)mg/dl 9.4(3.3)mg/dl
Brain Injury 10/27 6/26 5/25
ROP therapy 2(7.4%)
LOS 9(33.3%) 5(19.2%) 3(12%)
Hemodynamicall
y significant PDA
5(18.5%) 4(15.4%) 2(8%)

21. Limitations Of The Study
 Did not measure the effects of Delayed cord
clamping on blood Volume.
 Recorded only Short Term effects.
 Not Studied in Growth Retarded babies and Non
vigorous Neonates who required Resuscitation.
 Position of infants and Mode of Delivery was not
compared.
 Single Centre Study.
 Small Sample size

22. Conclusion
 In Preterm neonates delayed cord clamping along
with lowering the infant below perineum or
incision site and administration of ergometrine to
mother has significant benefits in terms of
increase in Hematocrit, Higher temperature on
admission, and higher blood pressure and
Urinary Output during Perinatal Transition.

23. What is already known?
 Delayed cord clamping in preterm neonates is
associated with improved hematocrit and less
incidence of anemia at 6-10 weeks of age.

24. What this study adds?
 This study demonstrates the cumulative effects of
(i) lowering the infant position by 10-15 cm below
the perineum/incision site;
(ii) administration of inj ergometrine; in addition to
delayed cord clamping on placental transfusion.
 This better placental transfusion, is associated
with less hypothermia on admission in NICU and
improved blood pressure and urinary output
during the perinatal transition.

25. Critical Appraisal
 Were the Following stated clearly?
1. Patients: Yes.
2. Intervention: Yes.
3. Comparison of Intervention: Yes.
4. Outcomes: Yes

26.  Was the Assignment of Patients to Treatment
Randomised?
Yes, Random Number Sequence with Variable
block size of 3 or 6 using a ‘Random Allocation
Software’ Program.
 Was the Randomisation list concealed?
Yes, Allocation concealment was done by
sequentially numbered sealed opaque envelopes.
Sequence was generated by a Statistician who was
not a part of the Study.

27.  Were all the Subjects who entered the Trial,
accounted for at its conclusion?
 Were they analysed in the groups in which
they were Randomised?
Yes, 78 mothers were subjected to the trial, all of
them were accounted for in the Result.
They were analysed in the groups in they were
randomised.

28.  Were the subjects and Clinicians blinded to
which treatment they have received?
No.
 Apart from the Experimental Treatment, were
the groups treated equally?
Yes, The Neonates were managed as per the
NICU protocol and outcome of the Intervention
done in the labour ward was observed.

29.  Were the groups similar at the start of the
Trial?
Yes.
 How Precise were the Results?
Results were not Presented with Confidence
Interval.

30.  Can this be applied to our Patients?
 Are my patients values and preferences
satisfied by the Intervention offered?
Yes.
Our patients are not different from the ones used in
the trial.
The Intervention of Delayed cord clamping can be
used in our setup.
Our patients values or preferences will not be
hindered or affected by Delayed cord clamping

31. Evidence Supporting this study
 Ibrahim, et al: 20 secs of Delayed cord clamping
can cause rise in Hematocrit at 4 hours of life.
 Oh, et al: 30-45 secs of Delayed Cord Clamping
can cause a rise in Hematocrit.
 Cochrane System Review: DCC is associated
with fewer transfusion requirements for anemia;
27 out 0f 100 babies spared a blood transfusion.

32.  Mc Dowel, et al: Found no difference in
Hematocrit with DCC.
 More evidence required to prove that DCC
reduces the incidence of LONS, ROP, NEC, BPD.

33.  Thank You