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Year : 2022  |  Volume : 1  |  Issue : 3  |  Page : 51-54

Study of coagulopathy in preterms: A prospective observational study

Aster MIMS Hospital, Calicut, Kerala, India

Date of Submission01-Mar-2023
Date of Decision02-May-2023
Date of Acceptance16-May-2023
Date of Web Publication29-Aug-2023

Correspondence Address:
Dr. Denna Ann Baby
Aster MIMS Hospital, Calicut, Kerala
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Source of Support: None, Conflict of Interest: None

DOI: 10.4103/pedc.pedc_2_23

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BACKGROUND: A lack of evidence surrounding the assessment of coagulation abnormalities in neonates points to an urgent need to have a consensus on normal values based on gestation and postnatal age, so that we can have a consistent practice in treating abnormal clotting profiles. OBJECTIVES: The primary objective of this study was to study the incidence of bleeding associated with and without coagulopathy in high-risk preterms using NeoBAT score and prothrombin time, activated partial thromboplastin clotting time values with a prospective observational study. The secondary objective of this study was to study the incidence of asymptomatic coagulopathy. MATERIALS AND METHODS: This was a prospective observational study conducted in a level 3 neonatal intensive care unit. All high-risk preterms less than 34 weeks were included in the study. The outcome was to study the incidence of bleeding associated with and without coagulopathy. RESULTS: The incidence of coagulopathy was 69.8%, whereas that of clinical bleeding manifestation was 6.7%. Of these, 6% was associated with coagulopathy and 0.7% was not associated with coagulopathy. Approximately 63.6% had asymptomatic coagulopathy. CONCLUSION: Asymptomatic coagulopathy is a common occurrence in preterms. Most of the coagulopathy may resolve on its own. Fresh frozen plasma administration alone is not protective against clinical bleeding.

Keywords: Bleeding, coagulopathy, preterm

How to cite this article:
Baby DA, Anand M R, Preetha R, Vishnu Mohan P T. Study of coagulopathy in preterms: A prospective observational study. Pediatr Companion 2022;1:51-4

How to cite this URL:
Baby DA, Anand M R, Preetha R, Vishnu Mohan P T. Study of coagulopathy in preterms: A prospective observational study. Pediatr Companion [serial online] 2022 [cited 2023 Oct 5];1:51-4. Available from: http://www.pediatriccompanionkerala.in/text.asp?2022/1/3/51/384598

  Introduction Top

In the neonatal population, abnormalities of standard coagulation tests are not uncommon.[1] The sick newborn infant is at risk of developing thrombotic and hemorrhagic problems in the postnatal period.[2] Multiple factors such as infection, respiratory distress, necrotizing enterocolitis, the presence of intravascular catheters, surgical procedures, dehydration, and liver disease can affect hemostatic balance.[3] Screening of coagulation shows laboratory coagulopathy in a significant number of admissions which can lead to greater use of blood products to correct this.[4] Moreover, coagulation values are not necessarily related to the risk of bleeding.[5] The NeoBAT tool, a novel bleeding assessment tool, facilitates prospective recording of bleeding events in neonatal intensive care unit (NICU) and may allow standardized bleeding assessments in high-risk populations.[6] Also, the observation that prophylactic fresh frozen plasma (FFP) administration to nonbleeding preterms reduces their risk of a subsequent hemorrhage is controversial. The clinical importance of this study is that there is a relative paucity of data about the transfusion practice guidelines in preterms. Neither the clinical characteristics that influence transfusion practice nor the importance of a specific transfusion threshold have been documented clearly. These facts point toward the need for further studies to provide enlightenment in this area. In this study, we aimed to study the incidence of coagulopathy and bleeding among high-risk preterms in a tertiary care center and to observe if FFP administration is necessary for normalization of deranged coagulation values. The results would help in achieving a better rationale in our clinical practice.

  Materials and methods Top

In our study, the primary objective was to study the incidence of bleeding associated with and without coagulopathy and the secondary objective was to study the incidence of asymptomatic coagulopathy in high-risk preterms, less than 34 weeks. The study was conducted in babies admitted in a level 111 NICU using NeoBAT score and prothrombin time (PT), activated partial thromboplastin clotting time (aPTT) values. After approval of the ethical committee, a prospective observational study was conducted for a period of 2 years in 300 high-risk preterms less than 34 weeks from December 2015 to December 2017. All inborn and outborn babies were included in the study. The gestational age of neonates was determined based on the New Ballard scoring system. The babies with risk factors that are known to predispose to coagulopathy and bleeding were also included as high risk in addition to NeoBAT score. The high-risk preterms were those babies with

  • 1 clinical bleeding manifestation as per NeoBAT score.[6]

  • 2 babies of mothers with
    • a. Pregnancy-induced hypertension[7]

    • b. Perinatal asphyxia[8]

    • c. Respiratory distress syndrome needs mechanical ventilation and surfactant.[9]

All referred preterm babies who already received blood products and preterms with bleeding manifestation due to isolated thrombocytopenia were excluded. All inborn babies received an Injection of Vitamin K 0.5 mg intramuscularly at birth after the initial stabilization in the labor room. Screening coagulation profile (PT and aPTT values) were done soon after birth for all high-risk babies < 34 weeks admitted in NICU. Measures were taken to ensure sampling by clean venipuncture without air bubbles and contamination of tissue fluid. PT and aPTT values were to be checked by the Wintrobe method. The data were analyzed using the Statistical Package for the Social Sciences (SPSS) software program, version 17.0 (SSPS, California, USA).

  Coagulopathy Top

The following reference ranges were used in the study [Table 1].
Table 1: Infant reference ranges of common coagulation tests

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The indications of FFP transfusion in this study were as follows:

  • 1. Positive NeoBAT score.

  • 2. In the babies with negative NeoBAT scores but with evidence of laboratory coagulation, the following criteria were considered.
    • a. Prolongation of PT and aPTT (isolated or both) more than 1.5 times the upper limit––FFP transfusion given along with the injection of Vitamin K.

    • b. Prolongation of PT and aPTT less than 1.5 times the upper limit, which persisted or worsened after 6 h.

  Results Top

Of the 300 high-risk preterm babies included in the study, 209 babies had coagulopathy and 91 had normal coagulation.

The incidence of coagulopathy is 69.8%.

Approximately 6.7% had clinical bleeding manifestations as per the NeoBAT score. Of these, 6% was associated with coagulopathy and 0.7% was not associated with coagulopathy.

The incidence of asymptomatic coagulopathy is 63.6%.

The flowchart given below gives an overview.


  Discussion Top

To the best of our knowledge, no other study has specifically looked into the incidence of coagulopathy in preterms.

The incidence of clinical bleeding manifestations is 6.7%. In a study using NeoBAT score, Venkatesh et al.[6] obtained an incidence of 25%. This difference could be due to the fact that their sample had a higher proportion of babies less than 28 weeks. From [Figure 1], one can see that, despite giving FFP, 9 out of 67 babies with higher elevation of PT, aPTT developed clinical bleeding. This shows that FFP administration need not be universally protective. Also, it reinforces the observation made by Motto et al.[11] that clinical bleeding can occur irrespective of the severity of deranged coagulation values and prophylactic FFP administration. This could point to the contributory role of mechanical factors like immature vascular endothelium in clinical bleeding in this age group predisposing them to a higher risk for coagulopathy and bleeding.[1],[2]
Figure 1: Overview of the study

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As in [Figure 2], there were 142 babies who had a prolongation of coagulation profile less than 1.5 times the upper limit. Of these, nine babies (6.3%) had bleeding manifestations. It can be inferred that standard coagulation tests do not always predict the risk of bleeding and should not form a strong basis for decisions on administrating FFP. This observation is in concordance with Sanchita et al.[12] who reinforces that standard coagulation profiles have significant limitations as predictors of bleeding.
Figure 2: Profile of babies with <1.5 times deranged coagulation

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Of 142 babies, 121 had a normalized coagulation status when repeated at 6 hours without FFP. None of them developed any bleeding manifestations during the follow-up period. Unnecessary FFP transfusion could be avoided in these babies. This is in accord with the observations by Motto et al.,[4] Stanforth et al.,[10] Christensen et al.,[11] which do not advocate FFP transfusion for normalization of coagulation profile unless bleeding manifestation arises.

Of 91 babies with normal coagulation profiles, 2 babies developed bleeding manifestations. This again reinforces that coagulation profiles cannot be considered as predictors of bleeding in neonates.[12]

  Conclusion Top

  1. Asymptomatic coagulopathy is a common occurrence in preterms.

  2. Most of the coagulopathy may resolve on its own.

  3. FFP administration alone is not protective of clinical bleeding.


  1. A randomized control trial might give a better insight into this problem.

  2. A serial trend of the lab coagulation parameters was not part of this study.

Financial support and sponsorship


Conflicts of interest

There are no conflicts of interest.

  References Top

Andrew M, Paes B, Milner R, Johnston M, Mitchell L, Tollefsen DM, et al. Development of the human coagulation system in the healthy premature infant. Blood 1988;72:1651-7.  Back to cited text no. 1
Massicotte P, Mitchell L, Andrew M Comparative study of coagulation systems in animals. In: Pediatic Research. Vol. 20. Hamilton, ON: McMaster University Medical Centre; 1986.  Back to cited text no. 2
Saxon house MA, Manco-Johanson MJ The evaluation and management of neonatal coagulation disorders. Semin Perinatol 2009;33:52-65.  Back to cited text no. 3
Stanworth SJ, Grant, C, Lowe D, Laffan M, New H, Murphy MF, et al. The use of fresh frozen plasma in England: High levels of inappropriate use in adults and children. Transfusion 2011;51:62-70.  Back to cited text no. 4
Heller C, Becker S, Scharrer I, Kreuz W Prothrombotic risk factors in childhood stroke and venous thrombosis. Eur J Pediatr 1999;158:S117-21.  Back to cited text no. 5
Vidheya V, Curley A, Khan R, Clarke P, Watts T, Josephson C, et al. A novel approach to standardised recording of bleeding in a high risk neonatal population. Arch Dis Child Fetal Neonatal Ed 2013;98:F260-3.  Back to cited text no. 6
Agarwal K, Narayan S, Kumari S, Agarwal AK. Correlation of coagulation abnormality with clinical outcome in neonates of mothers with PIH. J Indian Med Assoc 1988;96:171-3.  Back to cited text no. 7
Ruchi J, Verma N. Coagulation profile in neonates with perinatal asphyxia. Int J Contemp Pediatr 2019;6.  Back to cited text no. 8
Chessels JM, Wigglesworth JS Coagulation studies in preterm infants with respiratory distress and intracranial hemorrhage. Arch Dis Child 1972;47:564-70.  Back to cited text no. 9
Christensen RD, Baer VL, Lambert DK, Henry E, Ilstrup SJ, Bennett ST Reference intervals for common coagulation tests of preterm infants (CME). Transfusion 2014;54:627-32:quiz 626.  Back to cited text no. 10
Motto M, Vecchio AD, Chirico G. Fresh frozen plasma administration in the neonatal intensive care unit-evidence based guidelines. Clin Perinatol 2015;42:639-50.  Back to cited text no. 11
Pal S, Curley A, Stanworth SJ. Interpretation of clotting tests in the neonate. Arch Dis Child Fetal Neonatal Ed;2. 2015;100:F270-4.  Back to cited text no. 12


  [Figure 1], [Figure 2]

  [Table 1]


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