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(12) United States Patent (10) Patent No.: US 9,339.433 B2 Madigan Et Al

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(12) United States Patent (10) Patent No.: US 9,339.433 B2 Madigan Et Al USOO93394.33B2 (12) United States Patent (10) Patent No.: US 9,339.433 B2 Madigan et al. (45) Date of Patent: May 17, 2016 (54) METHODS OF DIAGNOSING AND TREATING Blunden, Tony, "Fading puppies—reality or myth?” In Practice, Jun. NEONATAL REVERSION TO FETAL 2012, vol. 34, 314-321. CONSCOUSNESS Dickey, E.J. et al., “Hypoxic Ischemic Encephalopathy—what can we learn from humans?' Review J Wet Intern Med 2011:25:1231 (71) Applicant: The Regents of the University of 1240. California, Oakland, CA (US) Dwyer, C.M. et al., “Invited review: Improving neonatal survival in Small ruminants: Science into practice.” Animal, C. The Animal Con (72) Inventors: John E. Madigan, Woodland, CA (US); sortium 2015, May 2015, pp. 1-11. Monica R. Aleman, West Sacramento, Freshman, Joni L., “Fading puppy and kitten syndrome: Do you know the signs?” Veterinary Medicine, Nov. 2005, 807-808. CA (US) Hess-Dudan, et al. 1996, "Neonatal maladjustment syndrome and 73) Assignee:9. The Regentsg of the UniversitVy of other neurological signs in the newborn foal: Part 1.” Equine Veteri nary Education 8(1):24-32. California, Oakland, CA (US) Hess-Dudan, et al. 1996, "Neonatal maladjustment syndrome and *) Notice: Subject to anyy disclaimer, the term of this other neurological signs in the newborn foal: Part 2.” Equine Veteri nary Education 8(2):79-83. patent is extended or adjusted under 35 Kelly, Tara, “Jamie Ogg, baby pronounced dead then revived by U.S.C. 154(b) by 0 days. mother's touch, celebrates second birthday this month.” The Huffington Post, posted Mar. 9, 2012., downloaded from http://www. (21) Appl. No.: 14/162,753 huffingtonpost.com/2012/03/09/jamie-ogg-back-to-life in 1333,297.html. (22) Filed: Jan. 24, 2014 Lagercrantz, Hugo, “The birth of consciousness.” Early Human Development 85 (2009) 557-558. (65) Prior Publication Data Lawn, Joy E., et al. 2010, “Kangaroo mother care' to prevent neo US 2014/O213563 A1 Jul. 31, 2014 natal deaths due to preterm birth complications.” International Jour nal of Epidemiology 2010:39:i144-il 54. Related U.S. Application Data Madigan, et al. 2012, "Allopregnanolone infusion induced neurobehavioural alterations in a neonatal foal: Is this a clue to the (60) Provisional application No. 61/756.957, filed on Jan. pathogenesis of neonatal maladjustment syndrome'?” Equine Veteri 25, 2013. nary Journal 44, Suppl. 41 (2012) 109-112. Majewska, et al. 2014, “Marked elevation of adrenal steroids, espe (51) Int. Cl. cially androgens, in Saliva of prepubertal autistic children.” Eur Child GOIN33/53 (2006.01) Adolesc Psychiatry (2014) 23:485-498. GOIN3L/00 (2006.01) Meade, Clare, "Fading syndrome in kittens.” In Practice, Jun. 2014, A6H 9/00 (2006.01) vol. 36, 266-276. GOIN33/74 (2006.01) Mee, John F. “Managing the calf at calving time.” The AABP Pro A6D 99/00 (2006.01) ceedings, vol. 41. Sep. 2008, 46-53. GOIN33/68 (2006.01) Mellor, D.J. et al., “Animal welfare implications of neonatal mortal (52) U.S. Cl. ity and morbidity in farm animals.” The Veterinary Journal 168 (2004) 118-133, Aug. 13, 2003. CPC ................ A61H 9/005 (2013.01); A61D 99/00 Mellor, David J., “Galloping colts, fetal feelings, and reassuring (2013.01); G0IN33/6893 (2013.01); G0IN regulations: putting animal-welfare science into practice.” Journal of 33/743 (2013.01); A61 H 2203/03 (2013.01): Veterinary Medical Education (JVME)37(1) 2010 AAVMC, 94-100. G0IN 2800/38 (2013.01) Mellor, D.J. et al., “Responsiveness, behavioural arousal and aware (58) Field of Classification Search ness in fetal and newborn lambs: experimental, practical and thera CPC .................... A61K 31/00; G01N 2333/91194: peutic implications.” New Zealand Veterinary Journal 51(1), 2-13, G01N 2500/00; C12Q 1/48 2003. See application file for complete search history. Mercer, Judith S. et al., “Evidence-based practices for the fetal to newborn transition.” Journal of Midwifery & Women's Health, vol. (56) References Cited 52, No. 3, May/Jun. 2007, 262-272. Rossdale, et al. 1995, “A Retrospective Study of Increased Plasma Progestagen Concentrations in Compromised Neonatal Foals.” PUBLICATIONS Reprod. Fertil. Dev. 7:567-575. Tascilar et al. (Annals of Oncology 10, Suppl. 4:S107-S110, 1999).* Toth, et al. 2012, “Evaluation of squeeze-induced somnolence in Tockman et al. (Cancer Research 52:271 1s-2718s, 1992).* neonatal foals.” Am J Vet Res. 73(12): 1881-1889. Diesch, T.J. et al., “Birth transitions: Pathophysiology, the onset of consciousness and possible implications for neonatal maladjustment * cited by examiner syndrome in the foal.” Equine Veterinary Journal 45 (2013) 656-660. https://vimeo.com/68410389. Primary Examiner — Lisa Cook https://vimeo.com/68095552. (74) Attorney, Agent, or Firm — Weaver Austin Villeneuve https://vimeo.com/62660440. & Sampson LLP https://vimeo.com/62660441. https://vimeo.com/62660442. (57) ABSTRACT https://www.youtube.com/watch?v=mKbwOv7e(QKc. Aleman, M. et al., "Abnormal plasma neuroactive progestogen This invention provides methods of diagnosing and treating derivatives in ill, neonatal foals presented to the neonatal intensive syndromes of reversion to fetal consciousness in a neonate. care unit.” Equine Vet J. Nov. 2013:45(6):661-5, epublished Apr. 22. 2013. 38 Claims, 6 Drawing Sheets U.S. Patent May 17, 2016 Sheet 1 of 6 US 9,339.433 B2 Pregnenolone Progesterone e 17OH-progesterone 5a-Dihydroprogesterone too Allopregnanolone Cortisol Fig. 1 U.S. Patent May 17, 2016 Sheet 2 of 6 US 9,339.433 B2 A -0- Healthy w8w Sick Control --&- NMS time (h) 400 -- Healthy rise Sick Control 300 axa. NWS s K 2OO i. 1 O O O.8 -O- Healthy w8 Sick Cotrol g O.6 ^x). NMS c 550.4 - S. g2 O.2 O.O O 24 48 time (h) Fig. 2A-C U.S. Patent May 17, 2016 Sheet 3 of 6 US 9,339.433 B2 D 30 : -o- Healthy e was Sick Control 220 x NMS S 3. -* SR, 10& Ci O 24 48 time (h) -0- Healthy reer Sick Contro ex- NMS time (h) Fig. 2D-E U.S. Patent May 17, 2016 Sheet 4 of 6 US 9,339.433 B2 U.S. Patent May 17, 2016 Sheet 5 of 6 US 9,339.433 B2 Fig. 4 U.S. Patent May 17, 2016 Sheet 6 of 6 US 9,339.433 B2 Fig. 5 US 9,339,433 B2 1. 2 METHODS OF DAGNOSING AND TREATING after parturition leading to neuronal cellular energy failure NEONATAL REVERSION TO FETAL and death (Drummond (1988) Equine Vet J 5, 41-43; Ross CONSCIOUSNESS dale (1972) Equine Vet J 4, 117-128; Ringger, et al., (2011).J Vet Intern Med 25, 132-137). Clinical signs are consistent CROSS-REFERENCE TO RELATED with brain hypoxia and include alterations in the state of APPLICATIONS consciousness from mild obtundation to stuporous to coma tose; abnormal behaviour such as lack of affinity for the mare, This application claims the benefit under 35 U.S.C. S 119 not nursing, Vocalization, and wandering; blindness; and par (e) of U.S. Provisional Application No. 61/756,957, filed on oxysmal activity Such as paddling and seizures (Palmer and Jan. 25, 2013, which is hereby incorporated herein by refer 10 Rossdale (1976) Res Vet Sci 20, 267-275). Histopathological ence in its entirety for all purposes. evidence of cerebral hemorrhage and hypoxia has been detected in some severely affected foals (Palmer and Ross FIELD dale (1976), supra). However, many foals do not have histo The present invention relates to methods of diagnosing and 15 logical evidence of hypoxia, edema or hemorrhage (Bernard, treating syndromes of reversion to fetal consciousness in a et al., In: Proceedings, 41st American Association of Equine neOnate. Practitioners, Lexington, Ky. pp. 222-224). Furthermore, many foals have a normal birth and recover quickly and fully BACKGROUND from the condition. This is in contrast to infants and newborn rats with asphyxia in which a significantly longer recovery Neonatal maladjustment syndrome (NMS) is a common time is needed and long-term neurological deficits are often disorder of neonatal foals that manifests within the first 72h manifest (Kiss, et al., (2009) Brian Res 1255, 42-50; van of life (Bernard, et al (1995) In: Proceedings, 41st American Handel, et al., (2007) Eur J Pediatr 166, 645-654). The fast Association of Equine Practitioners, Lexington, Ky. pp. 222 recovery with no apparent long-term deficits and lack of 224; Rossdale and Leadon, (1975) J Reprod Fertil 23, 658 25 evidence of hypoxia or ischemia in affected neonatal foals 661). The proposed mechanisms include hypoxic and Suggest that the syndrome may not be exclusively the result of ischaemic events prior to, during and shortly after parturition hypoxia. (Palmer and Rossdale, (1976) Res Vet Sci 20, 267-275). Neonatal foals have high concentrations of pregnanes at Affected foals exhibit neurological dysfunction such as sei birth which decrease rapidly over the first 48 hours of life Zures and altered States of consciousness, behaviour and 30 (Houghton, et al., (1991) J Reprod Fertill 44, 609-617). response to stimuli (Bernard et al. 1995, supra; Ringger, et al. Elevated concentrations of plasma pregnanes and a correla (2011).J Wet Intern Med25, 132-137). However, hypoxic and tion between decreasing levels of pregnanes and clinical ischaemic injury is not always identified upon histopathologi recovery have been reported (Rossdale, et al., (1995) Reprod cal evaluation, and long-term neurological deficits have been Fertil Dev 7, 567-575). Certain steroidal compounds, pre reportedly rare. Fetal corticosteroids, through activation of 35 dominantly 5-O. reduced pregnanes, appear to have important the hypothalamo-pituitary-adrenocortical (HPA) axis, con neuromodulatory roles (Baulieu, (1998) Psychoneuroendo tribute to the maturation of many organs and regulate the crinology 23, 963-987; Mellon and Griffin (2002) Trends transition between intra- and extrauterine life (Rossdale, Endocrinol Metab 13, 35-43; Robel and Baulieu, (1994) (2004) In: Proceedings, 51st American Association of Equine Trends Endocrinol Metab 5, 1-8).
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