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Normative Data for Thyroid Stimulating Hormone for Screening of Congenital Hypothyroidism

  • ICMR Task Force on Inherited Metabolic Disorders
Original Article

Abstract

Objective

To generate normative data for thyroid stimulating hormone (TSH) levels in heel prick samples collected from newborns from 24 h to 7 d of age.

Methods

Five regional laboratories were designated as the testing laboratories. Dried blood spots (DBS) from babies (> or = 34 wk of gestation) were collected by heel prick at least after 24 h and within seven days after birth. TSH estimation was done using time resolved fluoroimmunoassay. Values above 20mIU/L were labelled as presumptive positive. Hour interval specific normative data was categorized at 6 h intervals. Another category placed was division into 24–72 h category, 73–96 h and 99–168 h. Percentile charts were calculated across these specified intervals.

Results

Samples analysed were 104,006 collected cumulatively from the 5 centers. Of the total samples analysed for TSH, 92.8% had values less than 5 mIU/l. When TSH values were interpreted with respect to time, a steady decrease with time was observed. Of the babies' samples, 48,839 were collected between 24 and 48 h, 23,983 between 49 to 72 h and 30,883 were collected after 72 h. The mean TSH concentration demonstrated a steady decline from 24 h to 168 h. It is apparent that 10 mIU/l is the 97.5th percentile value even when corrected for gender, birth weight and age at sampling. Thus 10 mIU/l seems to be the right cutoff beyond which a second sample should be sought.

Conclusions

This is the largest series reported with a broader population mix with representations of both urban (including slums) as well as a rural population. As this study excluded preterm babies, the utility of cut offs generated is not applicable to this subset and also to critically sick neonates. However, this study gives a true representation of the normative values for majority of the newborns born at term with weight appropriate for the gestation.

Keywords

Newborn screening TSH Normative values 

Notes

Acknowledgements

Writing Group: Dr. Seema Kapoor, Dr. Madhulika Kabra, Dr. Mani Kalavani, Dr. Roli Mathur.

Steering Group: Late Dr. SS Aggarwal (Chairperson), Dr. I C Verma, Dr. Veena Kalra, Dr. Vasantha Muthuswamy and Dr. Vijay Kumar.

Co-Investigators:

AIIMS, New Delhi: Dr. Vinod Paul, Dr. Ashok Deorari, Dr. Sheffali Gulati, Dr. Ramesh Agarwal, Dr. Vandana Jain, Dr. Suman Vashishst, Dr. Suneeta Mittal;

MAMC, Delhi: Dr. AP Dubey, Dr. Siddharth Ramji, Dr. Sangeeta Yadav, Dr. Swaraj Batra, Dr. Sangeeta Gupta;

KEM Hospital Mumbai: Dr. Keya Lahiri, Dr. Ruchi Nanavati;

MEDISCAN Chennai: Dr. Sujatha Jagadeesh, Dr. Sudha Rathna Prabhu, Dr. K Saraswathi, Dr. Rathna Kumari;

IPGMER, Kolkata: Dr. Mitali Chatterjee, Dr. S. C. Biswas, Dr. Indranil Chakraborty, Dr. Tapas Som, Meena Jaishankar, Dr. Satinath Mukhopadhyay; Sandor, Hyderabad: Dr. A. I Dherai and Dr. Srimannarayana Rao;

NIMHANS Bangalore: Dr. D. Nagaraja.

Contributions

ARRD, MK, SK, MM, AS, SS: regional centres collected, analyzed the data and participated in patient care; RMP: data coordination of the study; RM: overall coordination of the study; PKN: quality assurance; RC: laboratory tests; SK, MK, RM, KM, RMP: wrote the manuscript; SK and ARRD will act as guarantor of the paper.

Compliance with Ethical Standards

Conflict of Interest

None.

Source of Funding

Indian Council of Medical Research.

References

  1. 1.
    Foley T, Kaplowitz PB, Kaye CI, Sundararajan S, Varma SK, American Academy of Pediatrics, Rose SR; section on endocrinology and committee on genetics, American Thyroid Association, Brown RS; public health committee, Lawson Wilkins pediatric Endocrine Society. Update of newborn screening and therapy for congenital hypothyroidism. Pediatrics. 2006;117:2290–303.Google Scholar
  2. 2.
    American Academy of Pediatrics AAP Section on Endocrinology and Committee on Genetics, and American Thyroid Association Committee on Public Health: newborn screening for congenital hypothyroidism: recommended guidelines. Pediatrics. 1993;91:1203–9.Google Scholar
  3. 3.
    Kumar V, Misra SK, Kaushal SK, Gupta SC, Khan AMA. Study on the effect of Janani Suraksha Yojana on antenatal registration and institutional deliveries in the Agra district of Uttar Pradesh. Indian J Public Health. 2015;59:54–7.CrossRefPubMedGoogle Scholar
  4. 4.
    Imamoglu EY, Gursoy T, Hayran M, Karatekin G, Ovali F. Nomogram-based evaluation of thyroid function in appropriate-for-gestational-age neonates in intensive care unit. J Perinatol. 2015;35:204–7.CrossRefPubMedGoogle Scholar
  5. 5.
    Mahachoklertwattana P, Sriphrapradang A, Supapannachart S, Pongsuwan A, Choubtum L, Rajatanavin R. Thyroid function in healthy Thai neonates. J Med Assoc Thail. 1999;82:S22–6.Google Scholar
  6. 6.
    Kapil U, Kabra M, Sareen N, Khenduja P, Pande S. Iodine nutrition status amongst neonates in Kangra district, Himachal Pradesh. J Trace Elem Med Biol. 2014;28:351–3.CrossRefPubMedGoogle Scholar
  7. 7.
    Gopalakrishnan V, Joshi K, Phadke S, et al. Newborn screening for congenital hypothyroidism, galactosemia and biotinidase deficiency in Uttar Pradesh, India. Indian Pediatr. 2014;51:701–5.CrossRefPubMedGoogle Scholar
  8. 8.
    Sheikhbahaei S, Mahdaviani B, Abdollahi A, Nayeri F. Serum thyroid stimulating hormone, total and free T4 during the neonatal period: establishing regional reference intervals. Indian J Endocrinol Metab. 2014;18:39–43.PubMedPubMedCentralGoogle Scholar
  9. 9.
    Yarhere IE, Jaja T, Oduwole A, et al. Normative thyroid-stimulating hormone values for healthy nigerian newborns. Horm Res Paediatr. 2016;85:22–8.CrossRefPubMedGoogle Scholar
  10. 10.
    Herbstman J, Apelberg BJ, Witter FR, Panny S, Goldman LR. Maternal, infant, and delivery factors associated with neonatal thyroid hormone status. Thyroid. 2008;18:67–76.CrossRefPubMedGoogle Scholar
  11. 11.
    Korada M, Pearce MS, Avis E, Turner S, Cheetham TTSH. Levels in relation to gestation, birth weight and sex. Horm Res. 2009;72:120–3.CrossRefPubMedGoogle Scholar

Copyright information

© Dr. K C Chaudhuri Foundation 2018

Authors and Affiliations

  • ICMR Task Force on Inherited Metabolic Disorders
    • 1
  1. 1.Maulana Azad Medical CollegeNew DelhiIndia

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